Co Breath Analysis Module & Monoxol II
FDA 510(k) K952694 · Bacharach, Inc.
510(k) numberK952694
Submission
- Device name
- Co Breath Analysis Module & Monoxol II
- Applicant
- Bacharach, Inc.
Bethesda, MD, US - Received
- June 14, 1995
- Decision date
- January 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1430
- Specialty
- Anesthesiology
Other 510(k)s with product code CCJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253119 | CoSense ETCO MonitorCCJ · Traditional | Capnia, Inc. | 05/29/2026SE |
| K211918 | iCOquit® Smokerlyzer®CCJ · Traditional | Bedfont Scientific, Ltd. | 12/21/2021SE |
| K201206 | Pivot Breath SensorCCJ · Traditional | Carrot, Inc. | 06/30/2021SE |
| K173238 | ToxCOCCJ · Traditional | Bedfont Scientific, Ltd. | 04/04/2019SE |
| K171129 | CO Check Pro, CO ScreenCCJ · Traditional | MD Diagnostics Limited | 03/02/2018SE |
| K171408 | Carbon Monoxide Breath Sensor System (COBSS)CCJ · Traditional | Carrot Sense, Inc. | 09/29/2017SE |
| K151107 | CoSense ETCO MonitorCCJ · Special | Capnia, Inc. | 07/22/2015SE |
| K130036 | Cosense Co MonitorCCJ · Traditional | Capnia, Inc. | 01/14/2014SE |
| K121768 | CosenseCCJ · Traditional | Capnia, Inc. | 10/31/2012SE |
| K082315 | EC50 Micro+ SmokerlyzerCCJ · Traditional | Bedfont Scientific, Ltd. | 02/01/2010SE |
Questions and answers
When was Co Breath Analysis Module & Monoxol II cleared by the FDA?
Co Breath Analysis Module & Monoxol II (K952694) received a 510(k) decision of Substantially Equivalent on January 29, 1996, 229 days after the submission was received.
What is the product code of K952694?
The FDA product code is CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1430.