FDA Product Code
FDA Product Code CCJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.1430
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253119 | CoSense ETCO Monitor | Capnia, Inc. | 2026-05-29 | Traditional | PDF ↗ |
| K211918 | iCOquit® Smokerlyzer® | Bedfont Scientific, Ltd. | 2021-12-21 | Traditional | PDF ↗ |
| K201206 | Pivot Breath Sensor | Carrot, Inc. | 2021-06-30 | Traditional | PDF ↗ |
| K173238 | ToxCO | Bedfont Scientific, Ltd. | 2019-04-04 | Traditional | PDF ↗ |
| K171129 | CO Check Pro, CO Screen | MD Diagnostics Limited | 2018-03-02 | Traditional | PDF ↗ |
| K171408 | Carbon Monoxide Breath Sensor System (COBSS) | Carrot Sense, Inc. | 2017-09-29 | Traditional | PDF ↗ |
| K151107 | CoSense ETCO Monitor | Capnia, Inc. | 2015-07-22 | Special | PDF ↗ |
| K130036 | COSENSE CO MONITOR | Capnia, Inc. | 2014-01-14 | Traditional | PDF ↗ |
| K121768 | COSENSE | Capnia, Inc. | 2012-10-31 | Traditional | PDF ↗ |
| K082315 | EC50 MICRO+ SMOKERLYZER | Bedfont Scientific, Ltd. | 2010-02-01 | Traditional | PDF ↗ |
| K080278 | TABATABA COTESTER | Fim Medical | 2008-11-28 | Traditional | PDF ↗ |
| K070259 | EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR | Bedfont Scientific, Ltd. | 2008-02-21 | Traditional | PDF ↗ |
| K000962 | PICO SMOKERLYZER, MODEL EC-50 | Bedfont Scientific, Ltd. | 2000-04-20 | Special | PDF ↗ |
| K950197 | MICROCO | Micro Direct, Inc. | 1996-10-17 | Traditional | PDF ↗ |
| K952694 | CO BREATH ANALYSIS MODULE & MONOXOL II | Bacharach, Inc. | 1996-01-29 | Traditional | PDF ↗ |
| K904633 | SPIROLOOP, MODIFICATION | Pneumedics, Inc. | 1991-03-12 | Traditional | PDF ↗ |
| K902113 | VITALOGRAPH - BREATHCO MONITOR | Mcneill Intl., Inc. | 1990-10-26 | Traditional | PDF ↗ |
| K900322 | CO/CMD-1 | Spirometrics, Inc. | 1990-04-30 | Traditional | PDF ↗ |
| K892841 | BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR | Bedfont Technical Instruments , Ltd. | 1989-10-05 | Traditional | PDF ↗ |
| K892524 | VITALOGRAPH-BREATHCO MONITOR | Vitalograph , Ltd. | 1989-05-05 | Traditional | PDF ↗ |
| K863420 | VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR | Vitalograph , Ltd. | 1987-01-15 | Traditional | PDF ↗ |
| K843845 | CO TEST | Erich Jaeger, Inc. | 1984-10-12 | Traditional | PDF ↗ |
| K833739 | CD-102 CARBON DIOXIDE ANALYZER/RECOR | Instrumentarium Corp. | 1983-12-16 | Traditional | PDF ↗ |
| K832655 | ECOLYZER #200/COHB ANALYZER SYS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-09-26 | Traditional | PDF ↗ |
| K802891 | ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT | Sherwood Medical Co. | 1980-12-19 | Traditional | PDF ↗ |
| K781871 | DIFFUSION OPTION, OMNI-LAB | Ohio Medical Products | 1979-01-02 | Traditional | PDF ↗ |
| K781746 | MINICO | Catalyst Research Corp. | 1978-12-05 | Traditional | PDF ↗ |
| K760169 | DIFFUSION SYSTEM, SINGLE-BREATH (47404A) | Hewlett-Packard Co. | 1976-07-20 | Traditional | PDF ↗ |
Product code CCJ · Class II · Anesthesiology. Data: openFDA.