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FDA 510(k)

INFINITT ULite

K-Number: K163290 · 2017-03-24

ApplicantInfinitt Co., Ltd.
Decision Date2017-03-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INFINITT ULite is a medical device manufactured by Infinitt Co., Ltd.. It received FDA 510(k) clearance on 2017-03-24 under approval number K163290. 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 INFINITT ULite?

INFINITT ULite is a medical device that received FDA 510(k) clearance on 2017-03-24. It is manufactured by Infinitt Co., Ltd.. The 510(k) number is K163290.

When was INFINITT ULite approved by the FDA?

INFINITT ULite received FDA 510(k) clearance on 2017-03-24, under approval number K163290.

What company makes INFINITT ULite?

INFINITT ULite is manufactured by Infinitt Co., Ltd..

What is the FDA product code for INFINITT ULite?

The FDA product code for INFINITT ULite 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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