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FDA 510(k)

Finebeam

K-Number: K202288 · 2021-11-19

ApplicantSNJ Co., Ltd.
Decision Date2021-11-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Finebeam is a medical device manufactured by SNJ Co., Ltd.. It received FDA 510(k) clearance on 2021-11-19 under approval number K202288. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Finebeam?

Finebeam is a medical device that received FDA 510(k) clearance on 2021-11-19. It is manufactured by SNJ Co., Ltd.. The 510(k) number is K202288.

When was Finebeam approved by the FDA?

Finebeam received FDA 510(k) clearance on 2021-11-19, under approval number K202288.

What company makes Finebeam?

Finebeam is manufactured by SNJ Co., Ltd..

What is the FDA product code for Finebeam?

The FDA product code for Finebeam is GEX. This falls under the Gastroenterology category.

Other Devices by SNJ Co., Ltd.

Related Devices (Code: GEX)

Official Source

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