SENSORY 6
FDA 510(k) clearance K862338 · decided 1986-09-03
Clearance details
- K-number
- K862338
- Device name
- SENSORY 6
- Applicant
- Brytech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-06-20
- Decision date
- 1986-09-03
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- HPG
- Device class
- 1
- Regulation number
- 886.5900
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Canada, CA
- 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 |
|---|---|---|
| PATHFINDER (K910601) | Nurion Industries | 1991-05-14 |
| LOW VISION ENHANCEMENT SYSTEM (LVES) (K910124) | Triangle Investments | 1991-04-10 |
| LASER CANE (K903558) | Nurion Industries | 1990-09-27 |
| POLARON (K902187) | Nurion Industries | 1990-08-08 |
| ALES (K823385) | Oms | 1983-03-09 |
| F4912 NIGHT VISION AID (K761215) | Itt Corp. | 1976-12-16 |
Recalls involving this device
No recalls on record reference this clearance.