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FDA 510(k)

FloPatch FP120

K-Number: K251114 · 2025-06-20

ApplicantFlosonics Medical
Decision Date2025-06-20
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FloPatch FP120 is a medical device manufactured by Flosonics Medical. It received FDA 510(k) clearance on 2025-06-20 under approval number K251114. 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 FP120?

FloPatch FP120 is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Flosonics Medical. The 510(k) number is K251114.

When was FloPatch FP120 approved by the FDA?

FloPatch FP120 received FDA 510(k) clearance on 2025-06-20, under approval number K251114.

What company makes FloPatch FP120?

FloPatch FP120 is manufactured by Flosonics Medical.

What is the FDA product code for FloPatch FP120?

The FDA product code for FloPatch FP120 is DPW.

Other Devices by Flosonics Medical

K222242FloPatch FP120 K223843FloPatch FP120 K252810FloPatch FP120

Related Devices (Code: DPW)

K152930PeriFlux6000Perimed AB K181269iCertaintyRfpi K172457Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDeltex Medical Limited K183574SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesHuntleigh Healthcare , Ltd. K191388FloPatch (FP110)Flosonics Medical (R/A 1929803 Ontario Corp.) K182494FlowMet-RLaser Associated Sciences, Inc.

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.

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