Audit
by Axonics Inc.
510(k) K822335
Audit is a medical device (FDA Class II; FDA product code EWO, Audiometer) made by Axonics Inc., cleared under FDA 510(k) K822335 on 7 Feb 1983, 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 | NumberK822335 | Date7 Feb 1983 | StatusActive |
Official records
- FDA 510(k) database K822335
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EWO
- FDA applicant
- Axonics, Inc.
- 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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- 101, 151, 161 PORTABLE AUDIOMETERS by Amplaid USA, Inc.
- TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER by Tracor Instruments, Inc.
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- MICROTEK MEDICAL'S SOUND STIKS by Microbio-Medics, Inc.
- ACOUSTIC APPRAISE CD-3 by Qualitone
- GSI Corti by Grason-Stadler, Inc.