HIVOX OTC Electrical Stimulator— 510(k) K190347

Substantially Equivalent

Hivox Biotek, Inc.

FDA 510(k) clearance K190347 for HIVOX OTC Electrical Stimulator, Substantially Equivalent on 2019-03-15. Applicant: Hivox Biotek, Inc..

Clearance details

Applicant: Hivox Biotek, Inc.
Product code: Code NUH
Advisory panel: Neurology
Date received: 2019-02-14
Decision date: 2019-03-15
Decision: Substantially Equivalent
Clearance type: Special
Location: New Taipei City, TW

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