AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY)— 510(k) K963047

Substantially Equivalent

Fenwick Hearing Instruments

FDA 510(k) clearance K963047 for AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY), Substantially Equivalent on 1996-09-10. Applicant: Fenwick Hearing Instruments. Device class: 1.

Clearance details

Applicant
Fenwick Hearing Instruments
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
Portland, OR, US
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