Hint Audiometer, or Hint
510(k) K003913
Hint Audiometer, or Hint is a medical device (FDA Class II; FDA product code EWO, Audiometer) made by Maico-Diagnostics, cleared under FDA 510(k) K003913 on 16 Mar 2001, 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 | NumberK003913 | Date16 Mar 2001 | StatusActive |
Official records
- FDA 510(k) database K003913
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- Withdrawn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
Similar devices
Other devices filed under FDA product code EWO (Audiometer).
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- GSI 17 SCREENING AUDIOMETER by Grason-Stadler, Inc.
- DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER by Kenneth Ullrich
- INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA) by Artifical Hearing Systems Corp.
- ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER by Grason-Stadler, Inc.
- 101, 151, 161 PORTABLE AUDIOMETERS by Amplaid USA, Inc.