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FDA 510(k)

Flowart

K-Number: K190806 · 2020-02-20

Decision Date2020-02-20
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Flowart is the device name listed in this FDA 510(k) record. The listed applicant is Asset Medikal Tasarim As.. It received FDA 510(k) clearance on 2020-02-20 under 510(k) number K190806. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flowart?

Flowart is a medical device that received FDA 510(k) clearance on 2020-02-20. The listed applicant is Asset Medikal Tasarim As.. The 510(k) number is K190806.

When did Flowart receive FDA 510(k) clearance?

Flowart received FDA 510(k) clearance on 2020-02-20, under 510(k) number K190806.

Who is the listed applicant for Flowart?

The FDA 510(k) record lists Asset Medikal Tasarim As. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flowart?

The FDA product code for Flowart is FPA.

Other records listing Asset Medikal Tasarim As. 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: FPA)

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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