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FDA 510(k)

LEICA COLPOSCOPE

K-Number: K000707 · 2000-06-27

ApplicantLeica Microscopy Systems , Ltd.
Decision Date2000-06-27
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LEICA COLPOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Leica Microscopy Systems , Ltd.. It received FDA 510(k) clearance on 2000-06-27 under 510(k) number K000707. 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 LEICA COLPOSCOPE?

LEICA COLPOSCOPE is a medical device that received FDA 510(k) clearance on 2000-06-27. The listed applicant is Leica Microscopy Systems , Ltd.. The 510(k) number is K000707.

When did LEICA COLPOSCOPE receive FDA 510(k) clearance?

LEICA COLPOSCOPE received FDA 510(k) clearance on 2000-06-27, under 510(k) number K000707.

Who is the listed applicant for LEICA COLPOSCOPE?

The FDA 510(k) record lists Leica Microscopy Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEICA COLPOSCOPE?

The FDA product code for LEICA COLPOSCOPE is HEX.

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Related Devices (Code: HEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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