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FDA 510(k)

Rapid Family

K-Number: K173169 · 2017-11-20

Decision Date2017-11-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Rapid Family is a medical device manufactured by Sharplight Technologies, Ltd.. It received FDA 510(k) clearance on 2017-11-20 under approval number K173169. 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 Rapid Family?

Rapid Family is a medical device that received FDA 510(k) clearance on 2017-11-20. It is manufactured by Sharplight Technologies, Ltd.. The 510(k) number is K173169.

When was Rapid Family approved by the FDA?

Rapid Family received FDA 510(k) clearance on 2017-11-20, under approval number K173169.

What company makes Rapid Family?

Rapid Family is manufactured by Sharplight Technologies, Ltd..

What is the FDA product code for Rapid Family?

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

Other Devices by Sharplight Technologies, Ltd.

Related Devices (Code: GEX)

Official Source

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