Identifiers
- 510(k) Number
- K831776 FDA 510(k)
- FDA Product Code
- CCK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1400 FDA 510(k)
- Regulation Number
- 868.1400 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Capnograph is a medical device used for monitoring carbon dioxide levels in a patient's exhaled breath. It provides real-time data to assist clinicians in assessing respiratory function and ventilation status.
This device is identified by FDA 510(k) number K831776. It was cleared for use under the anesthesiology advisory committee.
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: K831776 FDA 510(k) - CAPNOGRAPH | Datascope Corp., CAPNOGRAPH (K831776) — FDA 510(k) | Innolitics, Capnograph 510 (k) K831776 - FDA.report, Datascope Corp. FDA Filings - FDA.report, Datascope Corp. | DAIC
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K831776 | Class II | Active |
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Manufacturer
- Manufacturer
- Datascope Corp.
Sources (1)
- FDA 510(k) K831776 24 fields · synced Sep 21, 2026