PlasmaFlight
K-Number: K200351 · 2020-08-05
ApplicantManamed, Inc.
Decision Date2020-08-05
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
PlasmaFlight is a medical device manufactured by Manamed, Inc.. It received FDA 510(k) clearance on 2020-08-05 under approval number K200351. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PlasmaFlight?
PlasmaFlight is a medical device that received FDA 510(k) clearance on 2020-08-05. It is manufactured by Manamed, Inc.. The 510(k) number is K200351.
When was PlasmaFlight approved by the FDA?
PlasmaFlight received FDA 510(k) clearance on 2020-08-05, under approval number K200351.
What company makes PlasmaFlight?
PlasmaFlight is manufactured by Manamed, Inc..
What is the FDA product code for PlasmaFlight?
The FDA product code for PlasmaFlight is IRP.
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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.