HYPERSOUND AUDIO SYSTEM (HSS)— 510(k) K133352

Name: FDA 510(k) clearance K133352
Creator: U.S. Food and Drug Administration
Published: 2014-02-12

Substantially Equivalent

Hypersound Health, Inc.

FDA 510(k) clearance K133352 for HYPERSOUND AUDIO SYSTEM (HSS), Substantially Equivalent on 2014-02-12. Applicant: Hypersound Health, Inc.. Device class: 2.

Clearance details

Applicant: Hypersound Health, Inc.
Product code: Code EPF
Device class: Class 2
Regulation: 21 CFR 874.3320
Advisory panel: Ear, Nose, Throat
Date received: 2013-10-31
Decision date: 2014-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

Download summary PDF View on FDA.gov ↗

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