Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)— 510(k) K191346

Name: FDA 510(k) clearance K191346
Creator: U.S. Food and Drug Administration
Published: 2020-02-14

Substantially Equivalent

Blackrock Microsystems

FDA 510(k) clearance K191346 for Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids), Substantially Equivalent on 2020-02-14. Applicant: Blackrock Microsystems. Device class: 2.

Clearance details

Applicant: Blackrock Microsystems
Product code: Code GYC
Device class: Class 2
Regulation: 21 CFR 882.1310
Advisory panel: Neurology
Date received: 2019-05-20
Decision date: 2020-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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