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FDA 510(k)

GIQuant

K-Number: K211356 · 2021-11-08

ApplicantMotilent, Ltd.
Decision Date2021-11-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GIQuant is the device name listed in this FDA 510(k) record. The listed applicant is Motilent, Ltd.. It received FDA 510(k) clearance on 2021-11-08 under 510(k) number K211356. 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 GIQuant?

GIQuant is a medical device that received FDA 510(k) clearance on 2021-11-08. The listed applicant is Motilent, Ltd.. The 510(k) number is K211356.

When did GIQuant receive FDA 510(k) clearance?

GIQuant received FDA 510(k) clearance on 2021-11-08, under 510(k) number K211356.

Who is the listed applicant for GIQuant?

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

What is the FDA product code for GIQuant?

The FDA product code for GIQuant 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, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid 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.

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