CO-STAT End Tidal Breath Analyzer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K974805 FDA 510(k)
- FDA Product Code
- GHS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7425 FDA 510(k)
- Regulation Number
- 864.7425 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CO-STAT End Tidal Breath Analyzer is a medical device classified as an assay for carboxyhemoglobin, designed for non-invasive measurement of respiratory rate, end-tidal carbon dioxide concentration, and end-tidal carbon monoxide (corrected for background levels) in breath samples. It operates by analyzing exhaled gases to provide quantitative data, supporting clinical assessments in hematology and respiratory monitoring for neonates, children, and adults breathing spontaneously.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings, including hospitals and laboratories. It is regulated under FDA 510(k) clearance (K974805) and falls under device class II, adhering to regulatory standards for assay devices. The analyzer requires proper calibration and maintenance to ensure accurate measurements, with no specific sterility requirements stated beyond standard medical device hygiene protocols.
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: CO-STAT (TM) END TIDAL BREATH ANALYZER (K974805) - Innolitics, CO-STAT (TM) END TIDAL BREATH ANALYZER (K974805) - Innolitics, Natus Medical, Inc. FDA 510 (k) Products (1995-2010), Validation of the Natus CO-Stat™ End Tidal BreathAnalyzer ... - Springer
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K974805 | Class II | Active |
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Manufacturer
- Manufacturer
- Natus Medical, Inc.
Sources (1)
- FDA 510(k) K974805 24 fields · synced Oct 1, 2026