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Cochlear™ Osia® System +6 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K231204
by Cochlear
Identifiers
- 510(k) Number
- K231204 FDA 510(k)
- FDA Product Code
- PFO FDA 510(k)
- Models / Variants
- Cochlear™ Osia® System FDA 510(k)Cochlear™ Osia® OSI300 Implant FDA 510(k)Cochlear™ Magnet Cassette FDA 510(k)Cochlear™ Non-Magnetic Cassette FDA 510(k)Cochlear™ Osia® 2(I) Sound Processor FDA 510(k)Cochlear™ Osia® Fitting Software 2 FDA 510(k)Cochlear™ Osia® Smart App 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® System +6 more models by Cochlear — Class II — FDA_510K — listed in FDA 510(k) — 7 models — 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 | K231204 | Class II | Active |
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Manufacturer
- Manufacturer
- Cochlear
Sources (1)
- FDA 510(k) K231204 24 fields · synced Jun 18, 2026