FDA 510(k)

geko T-2 and geko Plus R-2

Número K: K180082 · 2018-02-11

Data da decisão2018-02-11

Código do produtoIPF

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Firstkind, Ltd.. The 510(k) number is K180082.

When did geko T-2 and geko Plus R-2 receive FDA 510(k) clearance?

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

Who is the listed applicant for geko T-2 and geko Plus R-2?

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

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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Fonte oficial

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