HyperSound Tinnitus Module— 510(k) K161331
Substantially EquivalentTurtle Beach Corporation
FDA 510(k) clearance K161331 for HyperSound Tinnitus Module, Substantially Equivalent on 2016-08-23. Applicant: Turtle Beach Corporation. Device class: 2.
Clearance details
- Applicant
- Turtle Beach Corporation
- Product code
- Code KLW
- Device class
- Class 2
- Regulation
- 21 CFR 874.3400
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code KLW
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