FDA 510(k)

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)

Numéro K : K191346 · 2020-02-14

Date de décision2020-02-14

Code produitGYC

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Blackrock Microsystems. The 510(k) number is K191346.

When did Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) receive FDA 510(k) clearance?

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

Who is the listed applicant for Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)?

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

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.

Essais cliniques associés

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Dispositifs connexes (Code : GYC)

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Source officielle

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