The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Eurostar Super, Eurostar Vfc.
Device ID | K942036 |
510k Number | K942036 |
Device Name: | EUROSTAR SUPER, EUROSTAR VFC |
Classification | Hearing Aid, Air Conduction |
Applicant | STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SO. Eden Prairie, MN 55344 |
Contact | Rick Stromberg |
Correspondent | Rick Stromberg STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SO. 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 | 1994-04-28 |
Decision Date | 1994-06-24 |