FDA 510(k)

SD LTM STIM Cortical Stimulator

Número K: K180761 · 2018-06-18

Data da decisão2018-06-18

Código do produtoGYC

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

SD LTM STIM Cortical Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Micromed S.P.A.. It received FDA 510(k) clearance on 2018-06-18 under 510(k) number K180761. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SD LTM STIM Cortical Stimulator?

SD LTM STIM Cortical Stimulator is a medical device that received FDA 510(k) clearance on 2018-06-18. The listed applicant is Micromed S.P.A.. The 510(k) number is K180761.

When did SD LTM STIM Cortical Stimulator receive FDA 510(k) clearance?

SD LTM STIM Cortical Stimulator received FDA 510(k) clearance on 2018-06-18, under 510(k) number K180761.

Who is the listed applicant for SD LTM STIM Cortical Stimulator?

The FDA 510(k) record lists Micromed S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SD LTM STIM Cortical Stimulator?

The FDA product code for SD LTM STIM Cortical Stimulator is GYC.

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