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FDA 510(k)

T-GEAR, MODEL TG/400-700

K-Number: K993224 · 2000-02-11

ApplicantDontech Products B.V.
Decision Date2000-02-11
Product CodeDZB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

T-GEAR, MODEL TG/400-700 is the device name listed in this FDA 510(k) record. The listed applicant is Dontech Products B.V.. It received FDA 510(k) clearance on 2000-02-11 under 510(k) number K993224. The device is classified under product code DZB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-GEAR, MODEL TG/400-700?

T-GEAR, MODEL TG/400-700 is a medical device that received FDA 510(k) clearance on 2000-02-11. The listed applicant is Dontech Products B.V.. The 510(k) number is K993224.

When did T-GEAR, MODEL TG/400-700 receive FDA 510(k) clearance?

T-GEAR, MODEL TG/400-700 received FDA 510(k) clearance on 2000-02-11, under 510(k) number K993224.

Who is the listed applicant for T-GEAR, MODEL TG/400-700?

The FDA 510(k) record lists Dontech Products B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T-GEAR, MODEL TG/400-700?

The FDA product code for T-GEAR, MODEL TG/400-700 is DZB.

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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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