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FDA 510(k)

CYCLETRAC CT-5000

K-Number: K073542 · 2008-02-14

ApplicantPt Products, LLC
Decision Date2008-02-14
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CYCLETRAC CT-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Pt Products, LLC. It received FDA 510(k) clearance on 2008-02-14 under 510(k) number K073542. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYCLETRAC CT-5000?

CYCLETRAC CT-5000 is a medical device that received FDA 510(k) clearance on 2008-02-14. The listed applicant is Pt Products, LLC. The 510(k) number is K073542.

When did CYCLETRAC CT-5000 receive FDA 510(k) clearance?

CYCLETRAC CT-5000 received FDA 510(k) clearance on 2008-02-14, under 510(k) number K073542.

Who is the listed applicant for CYCLETRAC CT-5000?

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

What is the FDA product code for CYCLETRAC CT-5000?

The FDA product code for CYCLETRAC CT-5000 is ITH.

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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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