The following data is part of a premarket notification filed by Sevrain-tech, Inc. with the FDA for Etv, Electronic Vision Aid.
| Device ID | K884540 |
| 510k Number | K884540 |
| Device Name: | ETV, ELECTRONIC VISION AID |
| Classification | Aid, Vision, Optical, Battery-powered |
| Applicant | SEVRAIN-TECH, INC. PARK CENTRE 8025 EXCELSIOR DRIVE, SUITE 1 Madison, WI 53717 |
| Contact | Heather R Schramm |
| Correspondent | Heather R Schramm SEVRAIN-TECH, INC. PARK CENTRE 8025 EXCELSIOR DRIVE, SUITE 1 Madison, WI 53717 |
| Product Code | HPE |
| CFR Regulation Number | 886.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-28 |
| Decision Date | 1989-01-19 |