The following data is part of a premarket notification filed by Brytech, Inc. with the FDA for Sensory 6.
| Device ID | K862338 |
| 510k Number | K862338 |
| Device Name: | SENSORY 6 |
| Classification | Aid, Vision, Electronic, Battery-powered |
| Applicant | BRYTECH, INC. BOX 8823 OTTAWA, ONTARIO Canada, CA K1g 3j2 |
| Contact | Bryenton |
| Correspondent | Bryenton BRYTECH, INC. BOX 8823 OTTAWA, ONTARIO Canada, CA K1g 3j2 |
| Product Code | HPG |
| CFR Regulation Number | 886.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-20 |
| Decision Date | 1986-09-03 |