Tinnitus Research Audiometer
510(k) K802560
Tinnitus Research Audiometer is a Class II device made by Starkey Laboratories, Inc., cleared under FDA 510(k) K802560 on 12 Nov 1980, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK802560 | Date12 Nov 1980 | StatusActive |
Official records
- FDA 510(k) database K802560
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EWO
- Device class
- Class II
- Regulation
- 21 CFR Part 874.1050
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
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