PlasmaWave
K-Number: K211253 · 2021-05-26
ApplicantManamed, Inc.
Decision Date2021-05-26
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
PlasmaWave is a medical device manufactured by Manamed, Inc.. It received FDA 510(k) clearance on 2021-05-26 under approval number K211253. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PlasmaWave?
PlasmaWave is a medical device that received FDA 510(k) clearance on 2021-05-26. It is manufactured by Manamed, Inc.. The 510(k) number is K211253.
When was PlasmaWave approved by the FDA?
PlasmaWave received FDA 510(k) clearance on 2021-05-26, under approval number K211253.
What company makes PlasmaWave?
PlasmaWave is manufactured by Manamed, Inc..
What is the FDA product code for PlasmaWave?
The FDA product code for PlasmaWave is JOW.
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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.