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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 a medical device manufactured by Motilent, Ltd.. It received FDA 510(k) clearance on 2021-11-08 under approval 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. It is manufactured by Motilent, Ltd.. The 510(k) number is K211356.

When was GIQuant approved by the FDA?

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

What company makes GIQuant?

GIQuant is manufactured by Motilent, Ltd..

What is the FDA product code for GIQuant?

The FDA product code for GIQuant is LLZ.

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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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