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FDA 510(k)

NEBA® Compact EEG2R Mobile Headset

K-Number: K223628 · 2023-03-02

ApplicantNeba Health, LLC
Decision Date2023-03-02
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEBA® Compact EEG2R Mobile Headset is a medical device manufactured by Neba Health, LLC. It received FDA 510(k) clearance on 2023-03-02 under approval number K223628. 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 NEBA® Compact EEG2R Mobile Headset?

NEBA® Compact EEG2R Mobile Headset is a medical device that received FDA 510(k) clearance on 2023-03-02. It is manufactured by Neba Health, LLC. The 510(k) number is K223628.

When was NEBA® Compact EEG2R Mobile Headset approved by the FDA?

NEBA® Compact EEG2R Mobile Headset received FDA 510(k) clearance on 2023-03-02, under approval number K223628.

What company makes NEBA® Compact EEG2R Mobile Headset?

NEBA® Compact EEG2R Mobile Headset is manufactured by Neba Health, LLC.

What is the FDA product code for NEBA® Compact EEG2R Mobile Headset?

The FDA product code for NEBA® Compact EEG2R Mobile Headset is OMC.

Related Clinical Trials

NCT07502937 A Multicenter Interventional Study on the Use of a 3-Degree-of-Freedom (3DOF) Platform to Evaluate the Safety and Usability of the System and Its Impact on Balance, Proprioception, and Neurological Deficits in the Rehabilitation of Patients With Neurological Disorders. NOT_YET_RECRUITING

Related Devices (Code: OMC)

K170363Ceribell Pocket EEG DeviceCeribell, Inc. K183529AE-120A EEG Head SetNihon Kohden Corporation K192549Byteflies KitByteflies NV K203827REMIEpitel, Inc. K221563Neurosteer EEG RecorderNeurosteer, Inc. K230933REMI Remote EEG Monitoring SystemEpitel, Inc.

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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