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FDA 510(k)

Biop Digital Colposcope

K-Number: K182764 · 2018-11-27

ApplicantBiop Medical , Ltd.
Decision Date2018-11-27
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Biop Digital Colposcope is a medical device manufactured by Biop Medical , Ltd.. It received FDA 510(k) clearance on 2018-11-27 under approval number K182764. 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 Biop Digital Colposcope?

Biop Digital Colposcope is a medical device that received FDA 510(k) clearance on 2018-11-27. It is manufactured by Biop Medical , Ltd.. The 510(k) number is K182764.

When was Biop Digital Colposcope approved by the FDA?

Biop Digital Colposcope received FDA 510(k) clearance on 2018-11-27, under approval number K182764.

What company makes Biop Digital Colposcope?

Biop Digital Colposcope is manufactured by Biop Medical , Ltd..

What is the FDA product code for Biop Digital Colposcope?

The FDA product code for Biop Digital Colposcope is HEX.

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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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