The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Bosch Eurostar.
Device ID | K933988 |
510k Number | K933988 |
Device Name: | BOSCH EUROSTAR |
Classification | Hearing Aid, Air Conduction |
Applicant | STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie, MN 55344 |
Contact | Jerrold Lang |
Correspondent | Jerrold Lang STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie, MN 55344 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-17 |
Decision Date | 1993-10-07 |