BioWaveGO RX
K-Number: K210202 · 2021-02-24
ApplicantBiowave Corporation
Decision Date2021-02-24
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
BioWaveGO RX is a medical device manufactured by Biowave Corporation. It received FDA 510(k) clearance on 2021-02-24 under approval number K210202. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BioWaveGO RX?
BioWaveGO RX is a medical device that received FDA 510(k) clearance on 2021-02-24. It is manufactured by Biowave Corporation. The 510(k) number is K210202.
When was BioWaveGO RX approved by the FDA?
BioWaveGO RX received FDA 510(k) clearance on 2021-02-24, under approval number K210202.
What company makes BioWaveGO RX?
BioWaveGO RX is manufactured by Biowave Corporation.
What is the FDA product code for BioWaveGO RX?
The FDA product code for BioWaveGO RX is GZJ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.