HEARING AID (ALL-IN-THE-EAR)— 510(k) K953960
Substantially EquivalentAudina Hearing Instrument
FDA 510(k) clearance K953960 for HEARING AID (ALL-IN-THE-EAR), Substantially Equivalent on 1995-09-12. 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
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