ETA
FDA 510(k) clearance K883853 · decided 1988-11-17
Clearance details
- K-number
- K883853
- Device name
- ETA
- Applicant
- Sevrain-Tech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-13
- Decision date
- 1988-11-17
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- LRA
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Madison, WI, 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 |
|---|---|---|
| WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER (K862471) | Institute of Logopedics | 1986-09-12 |
| TACTICON 1600 (K851441) | Medecon | 1985-06-27 |
| TEACHER TM (K851655) | Monargue Intl. | 1985-06-20 |
| KANIEVSKI SENSORY AID OR DEVICE (K843433) | Spectro Industries, Inc. | 1984-11-14 |
| TACTIL EAR (K831501) | Ear Three Systems | 1983-08-26 |
| TACTAID (K830418) | Audiological Engineering Corp. | 1983-03-10 |
| VIBRO-COM COMMUNICATOR #8827 (K813057) | Sonic Systems, Inc. | 1981-12-02 |
Recalls involving this device
No recalls on record reference this clearance.