REVERSING CLICK GENERATOR RCG6
FDA 510(k) clearance K771188 · decided 1977-07-14
Clearance details
- K-number
- K771188
- Device name
- REVERSING CLICK GENERATOR RCG6
- Applicant
- Teca, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-07-01
- Decision date
- 1977-07-14
- Days to decision
- 13 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 |
|---|---|---|
| AUDITORY STIMULATOR (K813557) | Western Advanced Technology, Inc. | 1982-01-19 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.