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FDA 510(k)

FloPatch (FP110)

K-Number: K191388 · 2019-06-21

ApplicantFlosonics Medical (R/A 1929803 Ontario Corp.)
Decision Date2019-06-21
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FloPatch (FP110) is the device name listed in this FDA 510(k) record. The listed applicant is Flosonics Medical (R/A 1929803 Ontario Corp.). It received FDA 510(k) clearance on 2019-06-21 under 510(k) 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. The listed applicant is Flosonics Medical (R/A 1929803 Ontario Corp.). The 510(k) number is K191388.

When did FloPatch (FP110) receive FDA 510(k) clearance?

FloPatch (FP110) received FDA 510(k) clearance on 2019-06-21, under 510(k) number K191388.

Who is the listed applicant for FloPatch (FP110)?

The FDA 510(k) record lists Flosonics Medical (R/A 1929803 Ontario Corp.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FloPatch (FP110)?

The FDA product code for FloPatch (FP110) is DPW.

Other records listing Flosonics Medical (R/A 1929803 Ontario Corp.) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200337FloPatch (FP120)

Related Devices (Code: DPW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260700BlueDop Vascular ExpertBlueDop Medical, Ltd.K252810FloPatch FP120Flosonics MedicalK251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)Remington Medical, Inc.K251114FloPatch FP120Flosonics MedicalK243852Elfor-LElfi-Tech , Ltd.K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)Remington Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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