Colposcope System— 510(k) K160341

Name: FDA 510(k) clearance K160341
Creator: U.S. Food and Drug Administration
Published: 2016-09-14

Substantially Equivalent

Xuzhou Kernel Medical Equipment Co., Ltd.

FDA 510(k) clearance K160341 for Colposcope System, Substantially Equivalent on 2016-09-14. Applicant: Xuzhou Kernel Medical Equipment Co., Ltd.. Device class: 2.

Clearance details

Applicant: Xuzhou Kernel Medical Equipment Co., Ltd.
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 2016-02-08
Decision date: 2016-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xuzhou, CN

Download summary PDF View on FDA.gov ↗

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