Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid— 510(k) K211954

Name: FDA 510(k) clearance K211954
Creator: U.S. Food and Drug Administration
Published: 2022-11-10

Substantially Equivalent

Spes Medica Srl

FDA 510(k) clearance K211954 for Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid, Substantially Equivalent on 2022-11-10. Applicant: Spes Medica Srl. Device class: 2.

Clearance details

Applicant: Spes Medica Srl
Product code: Code GYC
Device class: Class 2
Regulation: 21 CFR 882.1310
Advisory panel: Neurology
Date received: 2021-06-23
Decision date: 2022-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Battipaglia, IT

Download summary PDF View on FDA.gov ↗

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