Tinnitogram Signal Generator— 510(k) K221168
Substantially EquivalentGoldenear Company, Inc.
FDA 510(k) clearance K221168 for Tinnitogram Signal Generator, Substantially Equivalent on 2023-02-01. Applicant: Goldenear Company, Inc.. Device class: 2.
Clearance details
- Applicant
- Goldenear Company, Inc.
- 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
- Santa Clarita, CA, US
Recent devices under product code KLW
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