THE MODEL ACAPPELLA IN THE EAR HEARING AID— 510(k) K943961
Substantially EquivalentTelex Communications, Inc.
FDA 510(k) clearance K943961 for THE MODEL ACAPPELLA IN THE EAR HEARING AID, Substantially Equivalent on 1995-05-15. Applicant: Telex Communications, Inc.. Device class: 1.
Clearance details
- Applicant
- Telex Communications, Inc.
- 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
- Minneapolis, MN, US
Recent devices under product code ESD
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