HEARING AID (ALL-IN-THE-EAR)— 510(k) K953960

Substantially Equivalent

Audina Hearing Instrument

FDA 510(k) clearance K953960 for HEARING AID (ALL-IN-THE-EAR), Substantially Equivalent on 1995-09-12. Applicant: Audina Hearing Instrument. Device class: 1.

Clearance details

Applicant
Audina Hearing Instrument
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
Longwood, FL, US
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