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FDA 510(k)

OMEGATRAC, MODEL Z105

K-Number: K013307 · 2002-02-08

ApplicantTeftec Corp.
Decision Date2002-02-08
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OMEGATRAC, MODEL Z105 is the device name listed in this FDA 510(k) record. The listed applicant is Teftec Corp.. It received FDA 510(k) clearance on 2002-02-08 under 510(k) number K013307. 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 OMEGATRAC, MODEL Z105?

OMEGATRAC, MODEL Z105 is a medical device that received FDA 510(k) clearance on 2002-02-08. The listed applicant is Teftec Corp.. The 510(k) number is K013307.

When did OMEGATRAC, MODEL Z105 receive FDA 510(k) clearance?

OMEGATRAC, MODEL Z105 received FDA 510(k) clearance on 2002-02-08, under 510(k) number K013307.

Who is the listed applicant for OMEGATRAC, MODEL Z105?

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 OMEGATRAC, MODEL Z105?

The FDA product code for OMEGATRAC, MODEL Z105 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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