BioWave BioWraps
K-Number: K203158 · 2021-07-08
ApplicantBiowave Corporation
Decision Date2021-07-08
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
BioWave BioWraps is a medical device manufactured by Biowave Corporation. It received FDA 510(k) clearance on 2021-07-08 under approval number K203158. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BioWave BioWraps?
BioWave BioWraps is a medical device that received FDA 510(k) clearance on 2021-07-08. It is manufactured by Biowave Corporation. The 510(k) number is K203158.
When was BioWave BioWraps approved by the FDA?
BioWave BioWraps received FDA 510(k) clearance on 2021-07-08, under approval number K203158.
What company makes BioWave BioWraps?
BioWave BioWraps is manufactured by Biowave Corporation.
What is the FDA product code for BioWave BioWraps?
The FDA product code for BioWave BioWraps is GXY.
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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.