The following data is part of a premarket notification filed by Authorized Hearing Systems, Inc. with the FDA for Ahs Delta 22.
Device ID | K963879 |
510k Number | K963879 |
Device Name: | AHS DELTA 22 |
Classification | Hearing Aid, Air Conduction |
Applicant | AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST. Bristol, PA 19007 |
Contact | Henry Smith |
Correspondent | Henry Smith AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST. Bristol, PA 19007 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-26 |
Decision Date | 1996-11-26 |