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Datex-Ohmeda S/5tm Fm With L-Ficu04 And L-Ficu04a Software And N-Fcrec Module
FDA 510(k)Class II (US FDA 510(k))
510(k) K043276
Identifiers
- 510(k) Number
- K043276 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A comprehensive medical device directory listing the DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE.
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 | K043276 | Class II | Active |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- FDA Applicant
- Datex-Ohmeda
Sources (1)
- FDA 510(k) K043276 24 fields · synced Oct 6, 2026