FDA Product Code
FDA Product Code MLO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2800
510(k) Clearances — 33 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261580 | ZBPro Diagnostic (Version 2.0) | Zbeats, Inc. | 2026-09-11 | Traditional | PDF ↗ |
| K241890 | Philips Holter Analysis System | Philips Medizin Systeme Böblingen GmbH | 2025-03-21 | Traditional | PDF ↗ |
| K240794 | Frontier X Plus | Fourth Frontier Technologies Pvt, Ltd. | 2024-11-08 | Traditional | PDF ↗ |
| K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant, Inc. | 2020-09-02 | Traditional | PDF ↗ |
| K193177 | CER-S | Cardiocalm | 2020-08-26 | Traditional | PDF ↗ |
| K182030 | Faros Mobile | Bittium Biosignals , Ltd. | 2018-11-08 | Abbreviated | PDF ↗ |
| K140847 | CARDIOSPY ECG HOLTER SYSTEMS | Labtech Kft. | 2014-12-05 | Traditional | PDF ↗ |
| K131897 | CV3000 HOLTER ANALYSIS SYSTEM | Vales & Hills Biomedical Tech. , Ltd. | 2013-11-26 | Traditional | PDF ↗ |
| K130660 | AUDICOR CPAM WITH SDB (SINGLE SENSOR) | Inovise Medical, Inc. | 2013-10-11 | Traditional | PDF ↗ |
| K120462 | AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) | Inovise Medical, Inc. | 2012-09-20 | Traditional | PDF ↗ |
| K111487 | NH-301 AMBULATORY ECG ANALYSIS SOFTWARE | Norav Medical Corp. | 2011-11-10 | Special | PDF ↗ |
| K110569 | AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) | Inovise Medical, Inc. | 2011-10-24 | Traditional | PDF ↗ |
| K101273 | DYNAMIC ECG SYSTEM MODEL TLC5000 | Contec Medical System Co., Ltd. | 2011-09-30 | Traditional | PDF ↗ |
| K092853 | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM | Galix Biomedical Instrumentation, Inc. | 2010-07-09 | Traditional | PDF ↗ |
| K063339 | MEDICK MHM200 PERSONAL HEART MONITOR | Medick Healthcare , Ltd. | 2007-06-29 | Traditional | PDF ↗ |
| K062088 | PREMIER 11 HOLTER | Diagnostic Monitoring Software | 2006-08-25 | Special | PDF ↗ |
| K051730 | MATRIX HOLTER SYSTEM, MODEL M12 | Global Instrumentation, LLC | 2005-09-26 | Abbreviated | PDF ↗ |
| K042782 | SEER MC | Ge Medical Systems Information Technologies | 2005-09-02 | Traditional | PDF ↗ |
| K043454 | CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 | Medicomp, Inc. | 2005-03-24 | Special | PDF ↗ |
| K042108 | VISTA PLUS | Novacor | 2005-01-19 | Traditional | PDF ↗ |
| K040753 | R-TEST EVOLUTION 3 | Novacor | 2004-06-10 | Special | PDF ↗ |
| K024323 | CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 | Biomedical Systems Corp. | 2003-06-30 | Traditional | PDF ↗ |
| K031466 | IQMARK DIGITAL HOLTER | Brentwood Medical Technology Corp. | 2003-06-11 | Special | PDF ↗ |
| K012712 | NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 | Norav Medical , Ltd. | 2002-05-08 | Traditional | PDF ↗ |
| K010396 | C. NET 2100 | Cardionetics, Ltd. | 2001-10-04 | Traditional | PDF ↗ |
| K010949 | 2010 PLUS HOLTER FOR WINDOWS | Agilent Technologies | 2001-09-28 | Traditional | PDF ↗ |
| K004017 | H-SCRIBE | Mortara Instrument, Inc. | 2001-06-11 | Traditional | PDF ↗ |
| K992706 | GALIX GBI -3S-LP | Galix Biomedical Instrumentation, Inc. | 2001-03-15 | Traditional | PDF ↗ |
| K003940 | 2010 PLUS HOLTER FOR WINDOWS | Agilent Technologies | 2001-02-08 | Special | PDF ↗ |
| K003763 | 2010 PLUS HOLTER FOR WINDOWS | Agilent Technologies | 2001-01-05 | Special | PDF ↗ |
| K993788 | R.TEST EVOLUTION | Novacor Div. | 2000-08-04 | Traditional | PDF ↗ |
| K992197 | MODIFICATION TO ZYMED HOLTER 2000 | Zymed Medical Instrumentation | 1999-07-28 | Special | PDF ↗ |
| K990170 | HOLTER 2000 | Zymed Medical Instrumentation | 1999-04-13 | Special | PDF ↗ |
Product code MLO · Class II · Cardiovascular. Data: openFDA.