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FDA 510(k)

AE-120A EEG Head Set

K-Number: K183529 · 2019-03-19

ApplicantNihon Kohden Corporation
Decision Date2019-03-19
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AE-120A EEG Head Set is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Corporation. It received FDA 510(k) clearance on 2019-03-19 under 510(k) number K183529. 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 AE-120A EEG Head Set?

AE-120A EEG Head Set is a medical device that received FDA 510(k) clearance on 2019-03-19. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K183529.

When did AE-120A EEG Head Set receive FDA 510(k) clearance?

AE-120A EEG Head Set received FDA 510(k) clearance on 2019-03-19, under 510(k) number K183529.

Who is the listed applicant for AE-120A EEG Head Set?

The FDA 510(k) record lists Nihon Kohden Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AE-120A EEG Head Set?

The FDA product code for AE-120A EEG Head Set is OMC.

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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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