WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER— 510(k) K970974

Name: FDA 510(k) clearance K970974
Creator: U.S. Food and Drug Administration
Published: 1997-05-02

Substantially Equivalent

Williams Sound, LLC

FDA 510(k) clearance K970974 for WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER, Substantially Equivalent on 1997-05-02. Applicant: Williams Sound, LLC. Device class: 2.

Clearance details

Applicant: Williams Sound, LLC
Product code: Code LZI
Device class: Class 2
Regulation: 21 CFR 874.3320
Advisory panel: Ear, Nose, Throat
Date received: 1997-03-17
Decision date: 1997-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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