Identifiers
- 510(k) Number
- K200529 FDA 510(k)
- FDA Product Code
- LXV FDA 510(k)
Classification
- Device Class
- U FDA 510(k)
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Orion by Interacoustics A/S — U — 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 | K200529 | U | Active |
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Manufacturer
- Manufacturer
- Interacoustics A/S
Sources (1)
- FDA 510(k) K200529 24 fields · synced Jun 19, 2026