FloPatch (FP110)
K-Number: K191388 · 2019-06-21
Decision Date2019-06-21
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
FloPatch (FP110) is a medical device manufactured by Flosonics Medical (R/A 1929803 Ontario Corp.). It received FDA 510(k) clearance on 2019-06-21 under approval number K191388. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FloPatch (FP110)?
FloPatch (FP110) is a medical device that received FDA 510(k) clearance on 2019-06-21. It is manufactured by Flosonics Medical (R/A 1929803 Ontario Corp.). The 510(k) number is K191388.
When was FloPatch (FP110) approved by the FDA?
FloPatch (FP110) received FDA 510(k) clearance on 2019-06-21, under approval number K191388.
What company makes FloPatch (FP110)?
FloPatch (FP110) is manufactured by Flosonics Medical (R/A 1929803 Ontario Corp.).
What is the FDA product code for FloPatch (FP110)?
The FDA product code for FloPatch (FP110) is DPW.
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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.