Cosense Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
FDA 510(k)Class II (US FDA 510(k))
by Capnia, Inc.
Identifiers
- 510(k) Number
- K121768 FDA 510(k)
- FDA Product Code
- CCJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1430 FDA 510(k)
- Regulation Number
- 868.1430 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cosense is a gaseous-phase carbon-monoxide gas analyzer. It is designed to measure carbon monoxide levels in breath samples to assist in the assessment of hemolysis.
This device is regulated under FDA 510K clearance as a class 2 medical device. It is intended for use within the field of anesthesiology as specified by the regulatory classification.
Frequently asked questions
What is the primary clinical use of the Cosense analyzer?
The Cosense is a gaseous-phase carbon monoxide analyzer intended to measure carbon monoxide levels in breath samples. This measurement is used to assist clinicians in the assessment of hemolysis.
What is the regulatory classification of the Cosense device?
The Cosense is regulated as a class 2 medical device under FDA 510K clearance. It is categorized under the anesthesiology medical specialty with the product code CCJ.
Which medical specialty is this device intended for?
The device is intended for use within the field of anesthesiology. This is based on its regulatory classification and the advisory committee oversight for the device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CoSense® ETCOc Monitoring: Transformative Jaundice Management ... - Capnia, Capnia, Inc. - LinkedIn, CAPNIA CoSense ETCOc Monitoring and Indicating Devices, Capnia, Inc. - CoSense ETCOc Monitor - YouTube
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121768 | Class II | Active |
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Manufacturer
- Manufacturer
- Capnia, Inc.
Sources (1)
- FDA 510(k) K121768 24 fields · synced Sep 23, 2026