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FDA 510(k)

Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid

Número K: K211954 · 2022-11-10

RequerenteSpes Medica Srl
Data da decisão2022-11-10
Código do produtoGYC
Comité consultivoNE
DecisãoSubstantially Equivalent

Resumo do dispositivo

Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid is the device name listed in this FDA 510(k) record. The listed applicant is Spes Medica Srl. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K211954. 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 Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid?

Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Spes Medica Srl. The 510(k) number is K211954.

When did Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid receive FDA 510(k) clearance?

Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid received FDA 510(k) clearance on 2022-11-10, under 510(k) number K211954.

Who is the listed applicant for Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid?

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

What is the FDA product code for Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid?

The FDA product code for Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid is GYC.

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Dispositivos Relacionados (Código: GYC)

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Fonte oficial

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