FDA 510(k)

AE-120A EEG Head Set

K-Number: K183529 · 2019-03-19

Decision Date2019-03-19

Product CodeOMC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

AE-120A EEG Head Set is a medical device manufactured by Nihon Kohden Corporation. It received FDA 510(k) clearance on 2019-03-19 under approval 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. It is manufactured by Nihon Kohden Corporation. The 510(k) number is K183529.

When was AE-120A EEG Head Set approved by the FDA?

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

What company makes AE-120A EEG Head Set?

AE-120A EEG Head Set is manufactured by Nihon Kohden Corporation.

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

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

Other Devices by Nihon Kohden Corporation

K153707Nihon Kohden Vital Sign Telemeter K152305Nihon Kohden Afib Detection Program QP-039P K171765Nihon Kohden CO2 Monitor K171124Nihon Kohden Wireless Input Unit WEE-1200 K163644Nihon Kohden QP-160AK EEG Trend Program K163459Nihon Kohden Vital Sign Telemeter

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.