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FDA 510(k)

ALPHATRAC, MODEL A 205

K-Number: K022652 · 2002-11-21

ApplicantTeftec Corp.
Decision Date2002-11-21
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ALPHATRAC, MODEL A 205 is the device name listed in this FDA 510(k) record. The listed applicant is Teftec Corp.. It received FDA 510(k) clearance on 2002-11-21 under 510(k) number K022652. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHATRAC, MODEL A 205?

ALPHATRAC, MODEL A 205 is a medical device that received FDA 510(k) clearance on 2002-11-21. The listed applicant is Teftec Corp.. The 510(k) number is K022652.

When did ALPHATRAC, MODEL A 205 receive FDA 510(k) clearance?

ALPHATRAC, MODEL A 205 received FDA 510(k) clearance on 2002-11-21, under 510(k) number K022652.

Who is the listed applicant for ALPHATRAC, MODEL A 205?

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

What is the FDA product code for ALPHATRAC, MODEL A 205?

The FDA product code for ALPHATRAC, MODEL A 205 is ITI.

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Related Devices (Code: ITI)

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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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