IMAGE

Hearing Aid, Air Conduction

AUTHORIZED HEARING SYSTEMS, INC.

The following data is part of a premarket notification filed by Authorized Hearing Systems, Inc. with the FDA for Image.

Pre-market Notification Details

• Device ID: K944161
• 510k Number: K944161
• Device Name: IMAGE
• Classification: Hearing Aid, Air Conduction
• Applicant: AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST. Bristol, PA 19007
• Contact: Henry C Smith
• Correspondent: Henry C 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: 1994-08-26
• Decision Date: 1994-12-21