Identifiers
- 510(k) Number
- K853990 FDA 510(k)
- FDA Product Code
- JKS FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3220 FDA 510(k)
- Regulation Number
- 862.3220 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Osm3 Hemoximeter by Radiometer America, Inc. — Class I — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K853990 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Radiometer America, Inc.
Sources (1)
- FDA 510(k) K853990 24 fields · synced Jun 18, 2026