AM SERIES HEARING AID— 510(k) K973579

Substantially Equivalent

A & M Hearing, Ltd.

FDA 510(k) clearance K973579 for AM SERIES HEARING AID, Substantially Equivalent on 1997-10-28. Applicant: A & M Hearing, Ltd.. Device class: 1.

Clearance details

Applicant: A & M Hearing, Ltd.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1997-09-19
Decision date: 1997-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crawley, West Sussex, GB

Download summary PDF View on FDA.gov ↗

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