FDA 510(k)

1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4

K-Number: K100378 · 2010-04-28

Decision Date2010-04-28

Product CodeFTC

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 is the device name listed in this FDA 510(k) record. The listed applicant is Daavlin Distributing Co.. It received FDA 510(k) clearance on 2010-04-28 under 510(k) number K100378. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4?

1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 is a medical device that received FDA 510(k) clearance on 2010-04-28. The listed applicant is Daavlin Distributing Co.. The 510(k) number is K100378.

When did 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 receive FDA 510(k) clearance?

1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 received FDA 510(k) clearance on 2010-04-28, under 510(k) number K100378.

Who is the listed applicant for 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4?

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

What is the FDA product code for 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4?

The FDA product code for 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 is FTC.

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Related Devices (Code: FTC)

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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.