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FDA 510(k)

UV Phototherapy

K-Number: K181805 · 2019-01-11

Decision Date2019-01-11
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UV Phototherapy is a medical device manufactured by Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-01-11 under approval number K181805. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UV Phototherapy?

UV Phototherapy is a medical device that received FDA 510(k) clearance on 2019-01-11. It is manufactured by Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K181805.

When was UV Phototherapy approved by the FDA?

UV Phototherapy received FDA 510(k) clearance on 2019-01-11, under approval number K181805.

What company makes UV Phototherapy?

UV Phototherapy is manufactured by Xuzhou Kernel Medical Equipment Co., Ltd..

What is the FDA product code for UV Phototherapy?

The FDA product code for UV Phototherapy is FTC.

Other Devices by Xuzhou Kernel Medical Equipment Co., Ltd.

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Related Devices (Code: FTC)

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.