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FDA 510(k)

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)

K-Number: K191346 · 2020-02-14

ApplicantBlackrock Microsystems
Decision Date2020-02-14
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) is a medical device manufactured by Blackrock Microsystems. It received FDA 510(k) clearance on 2020-02-14 under approval number K191346. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)?

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) is a medical device that received FDA 510(k) clearance on 2020-02-14. It is manufactured by Blackrock Microsystems. The 510(k) number is K191346.

When was Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) approved by the FDA?

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) received FDA 510(k) clearance on 2020-02-14, under approval number K191346.

What company makes Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)?

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) is manufactured by Blackrock Microsystems.

What is the FDA product code for Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)?

The FDA product code for Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) is GYC.

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Related Devices (Code: GYC)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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