ITE HEARING AID, SOUND MED AMETHYST MODEL— 510(k) K903865

Name: FDA 510(k) clearance K903865
Creator: U.S. Food and Drug Administration
Published: 1990-10-09

Substantially Equivalent

Improved Hearing Service, Inc.

FDA 510(k) clearance K903865 for ITE HEARING AID, SOUND MED AMETHYST MODEL, Substantially Equivalent on 1990-10-09. Applicant: Improved Hearing Service, Inc.. Device class: 1.

Clearance details

Applicant: Improved Hearing Service, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1990-07-30
Decision date: 1990-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

Download summary PDF View on FDA.gov ↗

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K903415 — ITE HEARING AID, SOUND MED EMERALD MODEL1990-10-09
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K903860 — ITE HEARING AID, SAAPHIRE MODEL1990-10-09
K903861 — ITE HEARING AID, SOUND MED GOLDEN NUGGET MODEL1990-10-09
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Data sourced from openFDA. This site is unofficial and independent of the FDA.