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FDA 510(k)

FloPatch FP120

K-Number: K223843 · 2023-05-03

Decision Date2023-05-03
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FloPatch FP120 is the device name listed in this FDA 510(k) record. The listed applicant is Flosonics Medical. It received FDA 510(k) clearance on 2023-05-03 under 510(k) number K223843. 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 2023-05-03. The listed applicant is Flosonics Medical. The 510(k) number is K223843.

When did FloPatch FP120 receive FDA 510(k) clearance?

FloPatch FP120 received FDA 510(k) clearance on 2023-05-03, under 510(k) number K223843.

Who is the listed applicant for FloPatch FP120?

The FDA 510(k) record lists Flosonics Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FloPatch FP120?

The FDA product code for FloPatch FP120 is DPW.

Other records listing Flosonics Medical 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.

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.

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.