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FDA 510(k)

IMT LOUPE-COLPOSCOPE

K-Number: K963593 · 1997-04-22

ApplicantInventive Medical Technology
Decision Date1997-04-22
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IMT LOUPE-COLPOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Inventive Medical Technology. It received FDA 510(k) clearance on 1997-04-22 under 510(k) number K963593. 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 IMT LOUPE-COLPOSCOPE?

IMT LOUPE-COLPOSCOPE is a medical device that received FDA 510(k) clearance on 1997-04-22. The listed applicant is Inventive Medical Technology. The 510(k) number is K963593.

When did IMT LOUPE-COLPOSCOPE receive FDA 510(k) clearance?

IMT LOUPE-COLPOSCOPE received FDA 510(k) clearance on 1997-04-22, under 510(k) number K963593.

Who is the listed applicant for IMT LOUPE-COLPOSCOPE?

The FDA 510(k) record lists Inventive Medical Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMT LOUPE-COLPOSCOPE?

The FDA product code for IMT LOUPE-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.

K233043Smart Scope® CXPeriwinkle Technologies Pvt., Ltd.K190187Gynescope SystemIllumigyn , Ltd.K182764Biop Digital ColposcopeBiop Medical , Ltd.K181034Pocket Colposcope SystemHadleigh Health Technologies, LLCK170446LT-300 SD Digital Video ColposcopeLutech Industries, Inc.K161871EVA (Enhanced Visual Assessment) SystemMobileodt , Ltd.

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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