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FDA 510(k)

MARK I THERMAL IMAGER

K-Number: K023925 · 2003-02-11

ApplicantIx-Dr, Inc.
Decision Date2003-02-11
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MARK I THERMAL IMAGER is the device name listed in this FDA 510(k) record. The listed applicant is Ix-Dr, Inc.. It received FDA 510(k) clearance on 2003-02-11 under 510(k) number K023925. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARK I THERMAL IMAGER?

MARK I THERMAL IMAGER is a medical device that received FDA 510(k) clearance on 2003-02-11. The listed applicant is Ix-Dr, Inc.. The 510(k) number is K023925.

When did MARK I THERMAL IMAGER receive FDA 510(k) clearance?

MARK I THERMAL IMAGER received FDA 510(k) clearance on 2003-02-11, under 510(k) number K023925.

Who is the listed applicant for MARK I THERMAL IMAGER?

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

What is the FDA product code for MARK I THERMAL IMAGER?

The FDA product code for MARK I THERMAL IMAGER is LHQ.

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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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