FDA 510(k)

Neurosteer EEG Recorder

K-번호: K221563 · 2022-10-24

결정일2022-10-24

제품 코드OMC

자문 위원회NE

결정Substantially Equivalent

기기 요약

Neurosteer EEG Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Neurosteer, Inc.. It received FDA 510(k) clearance on 2022-10-24 under 510(k) number K221563. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Neurosteer EEG Recorder?

Neurosteer EEG Recorder is a medical device that received FDA 510(k) clearance on 2022-10-24. The listed applicant is Neurosteer, Inc.. The 510(k) number is K221563.

When did Neurosteer EEG Recorder receive FDA 510(k) clearance?

Neurosteer EEG Recorder received FDA 510(k) clearance on 2022-10-24, under 510(k) number K221563.

Who is the listed applicant for Neurosteer EEG Recorder?

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

What is the FDA product code for Neurosteer EEG Recorder?

The FDA product code for Neurosteer EEG Recorder is OMC.

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Neurosteer EEG Recorder

기기 요약

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관련 임상시험

관련 기기 (코드: OMC)

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