Blackrock NeuroCoG Subdural Cortical Electrodes (Strips And Grids)

Electrode, Cortical

Blackrock Microsystems

The following data is part of a premarket notification filed by Blackrock Microsystems with the FDA for Blackrock Neurocog Subdural Cortical Electrodes (strips And Grids).

Pre-market Notification Details

• Device ID: K191346
• 510k Number: K191346
• Device Name: Blackrock NeuroCoG Subdural Cortical Electrodes (Strips And Grids)
• Classification: Electrode, Cortical
• Applicant: Blackrock Microsystems 630 Komas Drive, Suite 200 Salt Lake City, UT 84108
• Contact: Rachelle Frischknecht
• Correspondent: Rachelle Frischknecht; Blackrock Microsystems 630 Komas Drive, Suite 200 Salt Lake City, UT 84108
• Product Code: GYC
• CFR Regulation Number: 882.1310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-05-20
• Decision Date: 2020-02-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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