IN-TH-EAR HEARING AID— 510(k) K850123

Substantially Equivalent

General Hearing Instruments, Inc.

FDA 510(k) clearance K850123 for IN-TH-EAR HEARING AID, Substantially Equivalent on 1985-03-21. Applicant: General Hearing Instruments, Inc.. Device class: 1.

Clearance details

Applicant
General Hearing Instruments, Inc.
Product code
Code ESD
Device class
Class 1
Regulation
21 CFR 874.3300
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Roanoke, VA, US
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