MODEL TM2-BEHIND-THE-EAR TINNITUS— 510(k) K792214
Substantially EquivalentStarkey Laboratories, Inc.
FDA 510(k) clearance K792214 for MODEL TM2-BEHIND-THE-EAR TINNITUS, Substantially Equivalent on 1979-11-27. Applicant: Starkey Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Starkey Laboratories, Inc.
- Product code
- Code BWF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5690
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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