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Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Sof…
FDA 510(k)Class II (US FDA 510(k))
510(k) K191921
Identifiers
- 510(k) Number
- K191921 FDA 510(k)
- FDA Product Code
- PFO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.3340 FDA 510(k)
- Regulation Number
- 874.3340 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Sof… by Cochlear Americas — Class II — FDA_510K — listed in FDA 510(k)
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 | K191921 | Class II | Active |
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Manufacturer
- Manufacturer
- Cochlear Americas
Sources (1)
- FDA 510(k) K191921 24 fields · synced Jun 18, 2026