DIAZIR— 510(k) K161652

Substantially Equivalent

Zxtgy (Beijing) Technology Co., Ltd.

FDA 510(k) clearance K161652 for DIAZIR, Substantially Equivalent on 2017-11-28. Applicant: Zxtgy (Beijing) Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zxtgy (Beijing) Technology Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2016-06-15
Decision date: 2017-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.