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FDA 510(k)

Neurosteer EEG Recorder

K-Number: K221563 · 2022-10-24

ApplicantNeurosteer, Inc.
Decision Date2022-10-24
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Neurosteer EEG Recorder?

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

When was Neurosteer EEG Recorder approved by the FDA?

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

What company makes Neurosteer EEG Recorder?

Neurosteer EEG Recorder is manufactured by Neurosteer, Inc..

What is the FDA product code for Neurosteer EEG Recorder?

The FDA product code for Neurosteer EEG Recorder is OMC.

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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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