OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID— 510(k) K897023

Name: FDA 510(k) clearance K897023
Creator: U.S. Food and Drug Administration
Published: 1990-03-16

Substantially Equivalent

Audina Hearing Instrument

FDA 510(k) clearance K897023 for OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID, Substantially Equivalent on 1990-03-16. Applicant: Audina Hearing Instrument. Device class: 1.

Clearance details

Applicant: Audina Hearing Instrument
Product code: Code LRB
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1989-12-19
Decision date: 1990-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longwood, FL, US

Download summary PDF View on FDA.gov ↗

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K936190 — BEHIND THE EAR HEARING AID1994-04-04
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.