PlasmaFlow
K-Number: K160318 · 2016-04-01
ApplicantManamed, Inc.
Decision Date2016-04-01
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
PlasmaFlow is a medical device manufactured by Manamed, Inc.. It received FDA 510(k) clearance on 2016-04-01 under approval number K160318. 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 PlasmaFlow?
PlasmaFlow is a medical device that received FDA 510(k) clearance on 2016-04-01. It is manufactured by Manamed, Inc.. The 510(k) number is K160318.
When was PlasmaFlow approved by the FDA?
PlasmaFlow received FDA 510(k) clearance on 2016-04-01, under approval number K160318.
What company makes PlasmaFlow?
PlasmaFlow is manufactured by Manamed, Inc..
What is the FDA product code for PlasmaFlow?
The FDA product code for PlasmaFlow 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.