AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR— 510(k) K964816
Substantially EquivalentAudina Hearing Instrument
FDA 510(k) clearance K964816 for AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR, Substantially Equivalent on 1997-01-17. Applicant: Audina Hearing Instrument. Device class: 1.
Clearance details
- Applicant
- Audina Hearing Instrument
- 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
- Longwood, FL, US
Recent devices under product code ESD
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