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FDA 510(k)

MEDCOM RT-VIEWER SYSTEM

K-Number: K100056 · 2010-05-07

ApplicantMedcom GmbH
Decision Date2010-05-07
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDCOM RT-VIEWER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medcom GmbH. It received FDA 510(k) clearance on 2010-05-07 under 510(k) number K100056. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDCOM RT-VIEWER SYSTEM?

MEDCOM RT-VIEWER SYSTEM is a medical device that received FDA 510(k) clearance on 2010-05-07. The listed applicant is Medcom GmbH. The 510(k) number is K100056.

When did MEDCOM RT-VIEWER SYSTEM receive FDA 510(k) clearance?

MEDCOM RT-VIEWER SYSTEM received FDA 510(k) clearance on 2010-05-07, under 510(k) number K100056.

Who is the listed applicant for MEDCOM RT-VIEWER SYSTEM?

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

What is the FDA product code for MEDCOM RT-VIEWER SYSTEM?

The FDA product code for MEDCOM RT-VIEWER SYSTEM is MUJ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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