MODEL C-1 HEARING AID— 510(k) K973043

Substantially Equivalent

Better Hearing, Inc.

FDA 510(k) clearance K973043 for MODEL C-1 HEARING AID, Substantially Equivalent on 1997-10-27. Applicant: Better Hearing, Inc.. Device class: 1.

Clearance details

Applicant: Better Hearing, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1997-08-15
Decision date: 1997-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herndon, VA, US

Download summary PDF View on FDA.gov ↗

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