CCJ · Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Anesthesiology · 21 CFR 868.1430 · Class 2
Overview
| Product Code | CCJ |
|---|---|
| Device Name | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase |
| Regulation | 21 CFR 868.1430 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K211918 | iCOquit® Smokerlyzer® | Bedfont Scientific, Ltd. | Dec 21, 2021 | SESE |
| K201206 | Pivot Breath Sensor | Carrot, Inc. | Jun 30, 2021 | SESE |
| K173238 | ToxCO | Bedfont Scientific, Ltd. | Apr 4, 2019 | SESE |
| K171129 | CO Check Pro, CO Screen | MD Diagnostics Limited | Mar 2, 2018 | SESE |
| K171408 | Carbon Monoxide Breath Sensor System (COBSS) | Carrot Sense, Inc. | Sep 29, 2017 | SESE |
| K151107 | CoSense ETCO Monitor | Capnia, Inc. | Jul 22, 2015 | SESE |
| K130036 | COSENSE CO MONITOR | Capnia, Inc. | Jan 14, 2014 | SESE |
| K121768 | COSENSE | Capnia, Inc. | Oct 31, 2012 | SESE |
| K082315 | EC50 MICRO+ SMOKERLYZER | Bedfont Scientific, Ltd. | Feb 1, 2010 | SESE |
| K080278 | TABATABA COTESTER | Fim Medical | Nov 28, 2008 | SESE |
| K070259 | EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR | Bedfont Scientific, Ltd. | Feb 21, 2008 | SESE |
| K000962 | PICO SMOKERLYZER, MODEL EC-50 | Bedfont Scientific, Ltd. | Apr 20, 2000 | SESE |
| K950197 | MICROCO | Micro Direct, Inc. | Oct 17, 1996 | SESE |
| K952694 | CO BREATH ANALYSIS MODULE & MONOXOL II | Bacharach, Inc. | Jan 29, 1996 | SESE |
| K904633 | SPIROLOOP, MODIFICATION | Pneumedics, Inc. | Mar 12, 1991 | SESE |
| K902113 | VITALOGRAPH - BREATHCO MONITOR | Mcneill Intl., Inc. | Oct 26, 1990 | SESE |
| K900322 | CO/CMD-1 | Spirometrics, Inc. | Apr 30, 1990 | SESE |
| K892841 | BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR | Bedfont Technical Instruments , Ltd. | Oct 5, 1989 | SESE |
| K892524 | VITALOGRAPH-BREATHCO MONITOR | Vitalograph , Ltd. | May 5, 1989 | SESE |
| K863420 | VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR | Vitalograph , Ltd. | Jan 15, 1987 | SESE |
Top Applicants
- Bedfont Scientific, Ltd. — 5 clearances
- Capnia, Inc. — 3 clearances
- Vitalograph , Ltd. — 2 clearances
- Spirometrics, Inc. — 1 clearance
- Sherwood Medical Co. — 1 clearance
