BEHIND THE EAR HEARING AID— 510(k) K936190

Name: FDA 510(k) clearance K936190
Creator: U.S. Food and Drug Administration
Published: 1994-04-04

Substantially Equivalent

Audina Hearing Instrument

FDA 510(k) clearance K936190 for BEHIND THE EAR HEARING AID, Substantially Equivalent on 1994-04-04. 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: 1993-12-27
Decision date: 1994-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Casselberry, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Audina Hearing Instrument

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K964816 — AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR1997-01-17
K953960 — HEARING AID (ALL-IN-THE-EAR)1995-09-12
K942236 — AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)1994-06-17
K930271 — BEHIND-THE-EAR HEARING AID1993-03-18
K897024 — MODEL AUDINA ITE HEATING AID1990-04-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.