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FDA 510(k)

DIAZIR

K-Number: K161652 · 2017-11-28

ApplicantZxtgy (Beijing) Technology Co., Ltd.
Decision Date2017-11-28
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIAZIR is a medical device manufactured by Zxtgy (Beijing) Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-11-28 under approval number K161652. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAZIR?

DIAZIR is a medical device that received FDA 510(k) clearance on 2017-11-28. It is manufactured by Zxtgy (Beijing) Technology Co., Ltd.. The 510(k) number is K161652.

When was DIAZIR approved by the FDA?

DIAZIR received FDA 510(k) clearance on 2017-11-28, under approval number K161652.

What company makes DIAZIR?

DIAZIR is manufactured by Zxtgy (Beijing) Technology Co., Ltd..

What is the FDA product code for DIAZIR?

The FDA product code for DIAZIR is EIH.

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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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