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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 the device name listed in this FDA 510(k) record. The listed applicant is Neba Health, LLC. It received FDA 510(k) clearance on 2023-03-02 under 510(k) 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. The listed applicant is Neba Health, LLC. The 510(k) number is K223628.

When did NEBA® Compact EEG2R Mobile Headset receive FDA 510(k) clearance?

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

Who is the listed applicant for NEBA® Compact EEG2R Mobile Headset?

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

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 Devices (Code: OMC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261101Ceribell MonitorCeribell, Inc.K251550NX01 (NX01)Naox Technologies SasK251726SignalNED System (Model RE)Forest Devices, Inc.K243185REMI Remote EEG Monitoring SystemEpitelK242930Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K232779QUEX ED; QUEX SQx World, Ltd.

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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