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FDA 510(k)

TRACKPORT

K-Number: K072529 · 2007-10-26

ApplicantDirex Systems Corp.
Decision Date2007-10-26
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRACKPORT is the device name listed in this FDA 510(k) record. The listed applicant is Direx Systems Corp.. It received FDA 510(k) clearance on 2007-10-26 under 510(k) number K072529. 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 TRACKPORT?

TRACKPORT is a medical device that received FDA 510(k) clearance on 2007-10-26. The listed applicant is Direx Systems Corp.. The 510(k) number is K072529.

When did TRACKPORT receive FDA 510(k) clearance?

TRACKPORT received FDA 510(k) clearance on 2007-10-26, under 510(k) number K072529.

Who is the listed applicant for TRACKPORT?

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

What is the FDA product code for TRACKPORT?

The FDA product code for TRACKPORT is IYE.

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Other records listing Direx Systems Corp. as applicant

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.

K111947DUET MAGNAK102765PRONEXK071701TRACKLEAF-10K063482CROSSPLAN / ACCUSOFT-XL V.4.04K062147INTEGRA SLK062032ACCUSOFT, ACCUSOFT XL

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Related Devices (Code: 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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