FDA 510(k)

블랙록 네우로코그 서드라이널 코르티컬 전극 (스트립과 그리드)

K-번호: K191346 · 2020-02-14

결정일2020-02-14

제품 코드GYC

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

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기기 요약

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.

자주 묻는 질문

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.

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