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FDA 510(k)

UNIVERSAL XACTTRACE

K-Number: K043132 · 2004-12-21

ApplicantMedcare Flaga
Decision Date2004-12-21
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL XACTTRACE is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Flaga. It received FDA 510(k) clearance on 2004-12-21 under 510(k) number K043132. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL XACTTRACE?

UNIVERSAL XACTTRACE is a medical device that received FDA 510(k) clearance on 2004-12-21. The listed applicant is Medcare Flaga. The 510(k) number is K043132.

When did UNIVERSAL XACTTRACE receive FDA 510(k) clearance?

UNIVERSAL XACTTRACE received FDA 510(k) clearance on 2004-12-21, under 510(k) number K043132.

Who is the listed applicant for UNIVERSAL XACTTRACE?

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

What is the FDA product code for UNIVERSAL XACTTRACE?

The FDA product code for UNIVERSAL XACTTRACE is MNR.

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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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