The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for _model Wc-1 Behind-the-ear Hearing Aid.
Device ID | K790745 |
510k Number | K790745 |
Device Name: | _MODEL WC-1 BEHIND-THE-EAR HEARING AID |
Classification | Hearing Aid, Air Conduction |
Applicant | STARKEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-16 |
Decision Date | 1979-05-01 |