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FDA 510(k)

VISITRAK, VERSION 1, RELEASE 1

K-Number: K050372 · 2005-03-25

ApplicantMath Resolutions, LLC
Decision Date2005-03-25
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISITRAK, VERSION 1, RELEASE 1 is the device name listed in this FDA 510(k) record. The listed applicant is Math Resolutions, LLC. It received FDA 510(k) clearance on 2005-03-25 under 510(k) number K050372. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISITRAK, VERSION 1, RELEASE 1?

VISITRAK, VERSION 1, RELEASE 1 is a medical device that received FDA 510(k) clearance on 2005-03-25. The listed applicant is Math Resolutions, LLC. The 510(k) number is K050372.

When did VISITRAK, VERSION 1, RELEASE 1 receive FDA 510(k) clearance?

VISITRAK, VERSION 1, RELEASE 1 received FDA 510(k) clearance on 2005-03-25, under 510(k) number K050372.

Who is the listed applicant for VISITRAK, VERSION 1, RELEASE 1?

The FDA 510(k) record lists Math Resolutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISITRAK, VERSION 1, RELEASE 1?

The FDA product code for VISITRAK, VERSION 1, RELEASE 1 is IYE.

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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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