TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II— 510(k) K964639
Substantially EquivalentTelex Communications, Inc.
FDA 510(k) clearance K964639 for TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II, Substantially Equivalent on 1997-01-21. 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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