FDA 510(k)

geko T-2 and geko Plus R-2

K-Number: K180082 · 2018-02-11

Decision Date2018-02-11

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

geko T-2 and geko Plus R-2 is a medical device manufactured by Firstkind, Ltd.. It received FDA 510(k) clearance on 2018-02-11 under approval number K180082. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the geko T-2 and geko Plus R-2?

geko T-2 and geko Plus R-2 is a medical device that received FDA 510(k) clearance on 2018-02-11. It is manufactured by Firstkind, Ltd.. The 510(k) number is K180082.

When was geko T-2 and geko Plus R-2 approved by the FDA?

geko T-2 and geko Plus R-2 received FDA 510(k) clearance on 2018-02-11, under approval number K180082.

What company makes geko T-2 and geko Plus R-2?

geko T-2 and geko Plus R-2 is manufactured by Firstkind, Ltd..

What is the FDA product code for geko T-2 and geko Plus R-2?

The FDA product code for geko T-2 and geko Plus R-2 is IPF.

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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.