MODEL AUDINA ITE HEATING AID— 510(k) K897024

Name: FDA 510(k) clearance K897024
Creator: U.S. Food and Drug Administration
Published: 1990-04-18

Substantially Equivalent

Audina Hearing Instrument

FDA 510(k) clearance K897024 for MODEL AUDINA ITE HEATING AID, Substantially Equivalent on 1990-04-18. 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: 1989-12-19
Decision date: 1990-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longwood, 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
K936190 — BEHIND THE EAR HEARING AID1994-04-04
K930271 — BEHIND-THE-EAR HEARING AID1993-03-18

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