ManaFlow
K-Number: K200353 · 2020-08-06
ApplicantManamed, Inc.
Decision Date2020-08-06
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ManaFlow is a medical device manufactured by Manamed, Inc.. It received FDA 510(k) clearance on 2020-08-06 under approval number K200353. 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 ManaFlow?
ManaFlow is a medical device that received FDA 510(k) clearance on 2020-08-06. It is manufactured by Manamed, Inc.. The 510(k) number is K200353.
When was ManaFlow approved by the FDA?
ManaFlow received FDA 510(k) clearance on 2020-08-06, under approval number K200353.
What company makes ManaFlow?
ManaFlow is manufactured by Manamed, Inc..
What is the FDA product code for ManaFlow?
The FDA product code for ManaFlow 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.