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FDA 510(k)

BioWaveGO

K-Number: K180943 · 2018-08-17

ApplicantBiowave Corporation
Decision Date2018-08-17
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BioWaveGO is a medical device manufactured by Biowave Corporation. It received FDA 510(k) clearance on 2018-08-17 under approval number K180943. 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?

BioWaveGO is a medical device that received FDA 510(k) clearance on 2018-08-17. It is manufactured by Biowave Corporation. The 510(k) number is K180943.

When was BioWaveGO approved by the FDA?

BioWaveGO received FDA 510(k) clearance on 2018-08-17, under approval number K180943.

What company makes BioWaveGO?

BioWaveGO is manufactured by Biowave Corporation.

What is the FDA product code for BioWaveGO?

The FDA product code for BioWaveGO is GZJ.

Other Devices by Biowave Corporation

K203158BioWave BioWraps K210202BioWaveGO RX

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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.

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