FDA 510(k)

geko T-2 and geko T-3 Neuromuscular Stimulators

Número K: K191113 · 2019-09-18

Data da decisão2019-09-18

Código do produtoIPF

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

geko T-2 and geko T-3 Neuromuscular Stimulators is the device name listed in this FDA 510(k) record. The listed applicant is Firstkind Limited. It received FDA 510(k) clearance on 2019-09-18 under 510(k) number K191113. 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 T-3 Neuromuscular Stimulators?

geko T-2 and geko T-3 Neuromuscular Stimulators is a medical device that received FDA 510(k) clearance on 2019-09-18. The listed applicant is Firstkind Limited. The 510(k) number is K191113.

When did geko T-2 and geko T-3 Neuromuscular Stimulators receive FDA 510(k) clearance?

geko T-2 and geko T-3 Neuromuscular Stimulators received FDA 510(k) clearance on 2019-09-18, under 510(k) number K191113.

Who is the listed applicant for geko T-2 and geko T-3 Neuromuscular Stimulators?

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

What is the FDA product code for geko T-2 and geko T-3 Neuromuscular Stimulators?

The FDA product code for geko T-2 and geko T-3 Neuromuscular Stimulators is IPF.

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Fonte oficial

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