FDA Product Code
FDA Product Code DPS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2340
510(k) Clearances — 578 records · page 1 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260250 | QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) | QT Medical, Inc. | 2026-09-29 | Traditional | PDF ↗ |
| K254255 | S-Patch CardioAI | Wellysis Corp. | 2026-09-25 | Traditional | PDF ↗ |
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | Edan Instruments, Inc. | 2026-07-02 | Traditional | PDF ↗ |
| K251670 | MAC 7 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2026-01-26 | Traditional | PDF ↗ |
| K252361 | AccurECG Analysis System (v2.0) | Accurkardia, Inc. | 2025-12-22 | Traditional | PDF ↗ |
| K252474 | Withings BeamO (SCT02) | Withings | 2025-11-10 | Traditional | PDF ↗ |
| K250569 | Cardiologs Holter Platform | Philips France Commercial | 2025-08-06 | Traditional | PDF ↗ |
| K243252 | ZBPro Diagnostic | Zbeats, Inc. | 2025-07-10 | Traditional | PDF ↗ |
| K243305 | Masimo W1 | Masimo Corporation | 2025-04-03 | Traditional | PDF ↗ |
| K241217 | CloudHRV System (100-01-001) | Inmedix, Inc. | 2025-01-16 | Traditional | PDF ↗ |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) | Philips Medizin Systeme Böblingen GmbH | 2024-12-17 | Traditional | PDF ↗ |
| K240229 | Masimo W1 | Masimo Corporation | 2024-08-08 | Traditional | PDF ↗ |
| K232161 | DeepRhythm Platform | Medicalgorithmics S.A. | 2024-06-20 | Traditional | PDF ↗ |
| K233266 | MEDIBLU ECG SYSTEM | Mediblu Medical, LLC | 2024-06-12 | Traditional | PDF ↗ |
| K232035 | Impala | AliveCor, Inc. | 2024-06-07 | Traditional | PDF ↗ |
| K232816 | Electrocardiograph, model: ECG301 | Shenzhen LE Medical Technology Co., Ltd. | 2024-06-07 | Traditional | PDF ↗ |
| K232445 | CSF-4 (CSF-4) | Cardiacsense | 2024-05-02 | Traditional | PDF ↗ |
| K232823 | MCG-S (AM1000) | Amcg Co., Ltd. | 2024-04-05 | Traditional | PDF ↗ |
| K231160 | Cardio Q50, Cardio Q70 | Bionet Co., Ltd. | 2023-12-15 | Traditional | PDF ↗ |
| K230834 | CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H | Trismed Co., Ltd. | 2023-11-21 | Traditional | PDF ↗ |
| K232974 | EKGenius Smart System | Ekgenius, LLC | 2023-11-17 | Traditional | PDF ↗ |
| K232512 | Masimo W1 | Masimo Corporation | 2023-11-17 | Traditional | PDF ↗ |
| K231150 | Cardio P1 | Bionet Co., Ltd. | 2023-11-09 | Traditional | PDF ↗ |
| K230812 | Withings Scan Monitor 2.0 | Withings | 2023-08-23 | Traditional | PDF ↗ |
| K223670 | MESI mTablet ECG Diagnostic System, MESI mTablet ECG | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | 2023-07-28 | Traditional | PDF ↗ |
| K222902 | Electrocardiograph: SE-1200 Pro and SE-1201 Pro | Edan Instruments, Inc. | 2023-07-28 | Traditional | PDF ↗ |
| K223013 | AccurECG Analysis System | Accurkardia, Inc. | 2023-06-23 | Traditional | PDF ↗ |
| K221260 | CSF-3 | Cardiacsense | 2023-01-06 | Traditional | PDF ↗ |
| K221141 | PageWriter TC35 Cardiograph | Medizin Systeme Boblingen GmbH | 2022-12-02 | Traditional | PDF ↗ |
| K220535 | Cardio10 | Bionet Co., Ltd. | 2022-11-15 | Traditional | PDF ↗ |
| K221321 | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2022-10-18 | Traditional | PDF ↗ |
| K212163 | Coala Heart Monitor | Coala Life AB | 2022-04-14 | Traditional | PDF ↗ |
| K212278 | Electrocardiograph | Edan Instruments, Inc. | 2022-04-07 | Traditional | PDF ↗ |
| K220362 | LE-12CH | Caf Medical Solutions, Inc. | 2022-03-25 | Traditional | PDF ↗ |
| K212112 | Cardiologs Holter Platform | Cardiologs Technologies | 2021-11-18 | Traditional | PDF ↗ |
| K201456 | Scan Monitor | Withings SA | 2021-10-05 | Traditional | PDF ↗ |
| K210140 | electrocardiograph: SE-1202 | Edan Instruments, Inc. | 2021-10-01 | Traditional | PDF ↗ |
| K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph | Philips Medical Systems | 2021-06-30 | Special | PDF ↗ |
| K203786 | MAC 7 - Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2021-04-30 | Traditional | PDF ↗ |
| K200884 | B-Secur HeartKey Software Library | B-Secur , Ltd. | 2020-12-07 | Traditional | PDF ↗ |
| K191738 | PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph | Philips Medical Systems | 2020-09-29 | Traditional | PDF ↗ |
| K193415 | physIQ Heart Rhythm and Respiration Module | Physiq, Inc. | 2020-06-11 | Traditional | PDF ↗ |
| K200036 | AI-ECG Tracker | Shenzhen Carewell Electronics Co., Ltd. | 2020-03-20 | Traditional | PDF ↗ |
| K183425 | CARDIOVIT AT-102 G2 | Schiller AG | 2020-03-02 | Traditional | PDF ↗ |
| K191692 | KardioScreen | Imedrix Inc. (Formerly Piitech Inc.) | 2020-01-10 | Traditional | PDF ↗ |
| K183322 | physIQ Heart Rhythm and Respiratory Module | Physiq, Inc. | 2019-07-10 | Traditional | PDF ↗ |
| K182571 | CardioFlux with Faraday Analytical Cloud | Genetesis, Inc. | 2019-03-15 | Traditional | PDF ↗ |
| K182093 | ZOLL ECG Analysis Software | Zoll Manufacturing Corporation | 2019-01-28 | Traditional | PDF ↗ |
| K183369 | COR12 ECG | Corscience GmbH & Co. | 2018-12-28 | Traditional | PDF ↗ |
| K182790 | Cardio-TriTest v6.5 | Cardio-Phoenix, Inc. | 2018-12-14 | Special | PDF ↗ |
| K181998 | CardioBand ECG Event Recorder | Samsung Strategy and Innovation Center (Ssic) | 2018-11-15 | Traditional | PDF ↗ |
| K173830 | MAC VU360 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2018-09-18 | Traditional | PDF ↗ |
| K173952 | Universal SmartECG | Vectracor, Inc. | 2018-08-28 | Traditional | PDF ↗ |
| K180234 | physiQ Heart Rhythm Module | Physiq, Inc. | 2018-08-10 | Traditional | PDF ↗ |
| K172778 | CheckMyHeart Plus | Dailycare Biomedical, Inc. | 2018-07-05 | Traditional | PDF ↗ |
| K172068 | Kenz Cardico1211 | Suzuken Co., Ltd. | 2018-06-01 | Traditional | PDF ↗ |
| K173226 | CardiMax Electrocardiograph | Fukuda Denshi USA, Inc. | 2018-04-16 | Traditional | PDF ↗ |
| K180242 | HeRO Symphony, HeRO ES, HeRO solo/duet | Medical Predictive Science Corporation | 2018-02-28 | Special | PDF ↗ |
| K162665 | MiCor A100 Wearable ECG Recorder | Mitac International Corp. | 2018-01-26 | Traditional | PDF ↗ |
| K171942 | Electrocardiograph | Edan Instruments, Inc. | 2018-01-24 | Special | PDF ↗ |
| K171360 | CONTEC Electrocardiograph | Contec Medical Systems Co.,Ltd | 2018-01-22 | Traditional | PDF ↗ |
| K171517 | Digital Electrocardiograph | Biocare Bio-Medical Equipment Co., Ltd. | 2018-01-11 | Special | PDF ↗ |
| K163607 | ECG Acquisition Systems | Vales & Hills Biomedical Tech. , Ltd. | 2017-12-15 | Traditional | PDF ↗ |
| K170154 | Creavo Vitalscan Magnetocardiograph | Creavo Medical Technologies, Ltd. | 2017-10-12 | Traditional | PDF ↗ |
| K171943 | Electrocardiograph | Edan Instruments, Inc. | 2017-09-25 | Traditional | PDF ↗ |
| K170182 | CARDIOVIT FT-1 | Schiller AG | 2017-07-19 | Traditional | PDF ↗ |
| K170568 | CardioLogs ECG Analysis Platform | Cardiologs Technologies | 2017-06-26 | Traditional | PDF ↗ |
| K170995 | Electrocardiograph | Edan Instruments, Inc. | 2017-06-02 | Traditional | PDF ↗ |
| K170954 | Portable ECG Monitor | Contec Medical Systems Co.,Ltd | 2017-05-30 | Traditional | PDF ↗ |
| K160667 | Anybattery C2 Rechargeable Battery | Anybattery, Inc. | 2017-05-11 | Traditional | PDF ↗ |
| K160876 | PC ECG | Edan Instruments, Inc. | 2017-02-15 | Traditional | PDF ↗ |
| K160746 | CARDIOLINE touchECG | Cardioline S.P.A | 2016-11-02 | Traditional | PDF ↗ |
| K160840 | ECG100+, ECG200+ | Cardioline S.P.A | 2016-08-12 | Traditional | PDF ↗ |
| K152135 | Quantitative Electrocardiographic Detector (QED 2000) | Acme Portable Machines, Inc. | 2016-08-09 | Traditional | PDF ↗ |
| K161302 | PC ECG | Edan Instruments, Inc. | 2016-07-01 | Traditional | PDF ↗ |
| K152863 | Portable ECG Monitor | Contec Medical Systems Co.,Ltd | 2016-06-22 | Traditional | PDF ↗ |
| K152043 | Diagnostic Station DS20 | Schiller AG | 2016-05-06 | Traditional | PDF ↗ |
| K151135 | MODEL 621/624 BIOMAGNETOMETER | Tristan Technologies, Inc. | 2016-03-15 | Traditional | PDF ↗ |
| K142969 | ANI Monitor | Mdoloris Medical Systems Sas | 2016-02-23 | Traditional | PDF ↗ |
| K160092 | Digital Electrocardiograph | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2016-02-12 | Special | PDF ↗ |
| K152427 | PC ECG | Edan Instruments, Inc. | 2016-02-05 | Traditional | PDF ↗ |
| K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems | Mortara Instrument, Inc. | 2016-01-06 | Traditional | PDF ↗ |
| K152384 | Digital Electrocardiograph | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2015-12-18 | Traditional | PDF ↗ |
| K150564 | Spaulding Electrocardiograph 2100iQ | Spaulding Clinical Research, LLC | 2015-08-12 | Traditional | PDF ↗ |
| K143432 | Cardio-TriTest | Cardio-Phoenix, Inc. | 2015-06-03 | Traditional | PDF ↗ |
| K143436 | InvisionECG System | Invisionheart, Inc. | 2015-05-21 | Traditional | PDF ↗ |
| K142551 | QANS (Quantitative Autonomic Nervous System) Monitoring System | Hhssystems, LLC | 2015-04-16 | Traditional | PDF ↗ |
| K142693 | ZywieAI Software Library | Zywie, Inc. | 2015-02-20 | Traditional | PDF ↗ |
| K141946 | DIGITAL ELECTROCARDIOGRAPH | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2015-02-13 | Traditional | PDF ↗ |
| K133985 | DIGITAL ELECTROCARDIOGRAPH | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2015-01-22 | Traditional | PDF ↗ |
| K142288 | MAC 800 Resting ECG Analysis System | Ge Medical Systems China Co., Ltd. | 2014-12-03 | Special | PDF ↗ |
| K140020 | HYPERQ ACS-100 SYSTEM | Bsp-Biiological Signal Processing, Ltd. | 2014-10-28 | Traditional | PDF ↗ |
| K142105 | ELI 380 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2014-09-05 | Special | PDF ↗ |
| K141582 | CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION | Welch Allyn | 2014-07-11 | Special | PDF ↗ |
| K131858 | DIGITAL ELECTROCARDIOGRAPH | Guangdong Biolight Meditech Co., Ltd. | 2014-06-11 | Traditional | PDF ↗ |
| K131900 | CONTEC ELECTROCARDIOGRAPH | Contec Medical System Co., Ltd. | 2014-03-05 | Traditional | PDF ↗ |
| K131503 | SE-601 SERIES ELECTROCARDIOGRAPH | Edan Instruments, Inc. | 2014-02-25 | Traditional | PDF ↗ |
| K122632 | GUAVA II | Cardiocomm Solutions, Inc. | 2014-02-11 | Traditional | PDF ↗ |
| K130921 | ALIVECOR HEART MONITOR OTC | AliveCor, Inc. | 2014-02-06 | Traditional | PDF ↗ |
| K132758 | DIGITAL ELECTROCARDIOGRAPH | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2014-01-30 | Special | PDF ↗ |
Product code DPS · Class II · Cardiovascular. Data: openFDA.