The following data is part of a premarket notification filed by Sevrain-tech, Inc. with the FDA for Eta.
| Device ID | K883853 |
| 510k Number | K883853 |
| Device Name: | ETA |
| Classification | Hearing Aid, Tactile |
| 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 | LRA |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-13 |
| Decision Date | 1988-11-17 |