SOLACE SOUND GENERATORS— 510(k) K132965

Name: FDA 510(k) clearance K132965
Creator: U.S. Food and Drug Administration
Published: 2014-03-25

Substantially Equivalent

Amplisound Hearing Products & Services

FDA 510(k) clearance K132965 for SOLACE SOUND GENERATORS, Substantially Equivalent on 2014-03-25. Applicant: Amplisound Hearing Products & Services. Device class: 2.

Clearance details

Applicant: Amplisound Hearing Products & Services
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2013-09-20
Decision date: 2014-03-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Danielson, CT, 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.