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FDA 510(k)

Colposcope System

K-Number: K160341 · 2016-09-14

ApplicantXuzhou Kernel Medical Equipment Co., Ltd.
Decision Date2016-09-14
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Colposcope System is a medical device manufactured by Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2016-09-14 under approval number K160341. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Colposcope System?

Colposcope System is a medical device that received FDA 510(k) clearance on 2016-09-14. It is manufactured by Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K160341.

When was Colposcope System approved by the FDA?

Colposcope System received FDA 510(k) clearance on 2016-09-14, under approval number K160341.

What company makes Colposcope System?

Colposcope System is manufactured by Xuzhou Kernel Medical Equipment Co., Ltd..

What is the FDA product code for Colposcope System?

The FDA product code for Colposcope System is HEX.

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Related Devices (Code: HEX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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