OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID— 510(k) K893528
Substantially EquivalentOticon Corp.
FDA 510(k) clearance K893528 for OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID, Substantially Equivalent on 1989-08-15. Applicant: Oticon Corp.. Device class: 1.
Clearance details
- Applicant
- Oticon Corp.
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerset, NJ, US
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