BioWaveGO RX— 510(k) K210202

Substantially Equivalent

Biowave Corporation

FDA 510(k) clearance K210202 for BioWaveGO RX, Substantially Equivalent on 2021-02-24. Applicant: Biowave Corporation. Device class: 2.

Clearance details

Applicant: Biowave Corporation
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2021-01-25
Decision date: 2021-02-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Norwalk, 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.