Colposcope System— 510(k) K160341

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..

Clearance details

Applicant: Xuzhou Kernel Medical Equipment Co., Ltd.
Product code: Code HEX
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 ↗

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