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FDA 510(k)

INTERMED ZOOM COLPOSCOPE

K-Number: K031639 · 2003-08-22

ApplicantIntermed Group, Inc.
Decision Date2003-08-22
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INTERMED ZOOM COLPOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Intermed Group, Inc.. It received FDA 510(k) clearance on 2003-08-22 under 510(k) number K031639. 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 INTERMED ZOOM COLPOSCOPE?

INTERMED ZOOM COLPOSCOPE is a medical device that received FDA 510(k) clearance on 2003-08-22. The listed applicant is Intermed Group, Inc.. The 510(k) number is K031639.

When did INTERMED ZOOM COLPOSCOPE receive FDA 510(k) clearance?

INTERMED ZOOM COLPOSCOPE received FDA 510(k) clearance on 2003-08-22, under 510(k) number K031639.

Who is the listed applicant for INTERMED ZOOM COLPOSCOPE?

The FDA 510(k) record lists Intermed Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTERMED ZOOM COLPOSCOPE?

The FDA product code for INTERMED ZOOM 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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