The following data is part of a premarket notification filed by Innovative Hearing Corp. with the FDA for Innovative Hearing Corp. #ihc 1000.
Device ID | K832633 |
510k Number | K832633 |
Device Name: | INNOVATIVE HEARING CORP. #IHC 1000 |
Classification | Hearing Aid, Air Conduction |
Applicant | INNOVATIVE HEARING CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-04 |
Decision Date | 1983-11-21 |