The following data is part of a premarket notification filed by Unitron Industries, Inc. with the FDA for Hearing Aid (model 695d, 905 & 960p).
Device ID | K760996 |
510k Number | K760996 |
Device Name: | HEARING AID (MODEL 695D, 905 & 960P) |
Classification | Hearing Aid, Air Conduction |
Applicant | UNITRON INDUSTRIES, 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 | 1976-11-08 |
Decision Date | 1976-11-16 |