FDA 510(k)

GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System

K-Number: K160065 · 2016-05-20

ApplicantGemss Medical Systems Co., Ltd.

Decision Date2016-05-20

Product CodeOXO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System is a medical device manufactured by Gemss Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2016-05-20 under approval number K160065. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System?

GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System is a medical device that received FDA 510(k) clearance on 2016-05-20. It is manufactured by Gemss Medical Systems Co., Ltd.. The 510(k) number is K160065.

When was GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System approved by the FDA?

GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System received FDA 510(k) clearance on 2016-05-20, under approval number K160065.

What company makes GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System?

GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System is manufactured by Gemss Medical Systems Co., Ltd..

What is the FDA product code for GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System?

The FDA product code for GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System is OXO.

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Other Devices by Gemss Medical Systems Co., Ltd.

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Official Source

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