OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44— 510(k) K901292
Substantially EquivalentOticon Corp.
FDA 510(k) clearance K901292 for OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44, Substantially Equivalent on 1990-04-10. 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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