FDA 510(k)

ProKnow DS

K-Number: K182855 · 2019-01-02

Decision Date2019-01-02

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ProKnow DS is the device name listed in this FDA 510(k) record. The listed applicant is Proknow, LLC. It received FDA 510(k) clearance on 2019-01-02 under 510(k) number K182855. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProKnow DS?

ProKnow DS is a medical device that received FDA 510(k) clearance on 2019-01-02. The listed applicant is Proknow, LLC. The 510(k) number is K182855.

When did ProKnow DS receive FDA 510(k) clearance?

ProKnow DS received FDA 510(k) clearance on 2019-01-02, under 510(k) number K182855.

Who is the listed applicant for ProKnow DS?

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

What is the FDA product code for ProKnow DS?

The FDA product code for ProKnow DS is LLZ.

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, 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.