AUDITORY STIMULATOR
FDA 510(k) clearance K813557 · decided 1982-01-19
Clearance details
- K-number
- K813557
- Device name
- AUDITORY STIMULATOR
- Applicant
- Western Advanced Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-22
- Decision date
- 1982-01-19
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- ETS
- Device class
- 2
- Regulation number
- 874.1120
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OCTOTOXIC SCREENER (K811790) | Western Advanced Technology, Inc. | 1981-07-15 |
| AUDITORY LOCALIZER (K811772) | Western Advanced Technology, Inc. | 1981-07-15 |
| TINNITUS DEVICES (K790064) | Vicon Instrument Co. | 1979-02-16 |
| REVERSING CLICK GENERATOR RCG6 (K771188) | Teca, Inc. | 1977-07-14 |
Recalls involving this device
No recalls on record reference this clearance.