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FDA 510(k)

Nihon Kohden QP-160AK EEG Trend Program

K-Number: K163644 · 2017-05-19

ApplicantNihon Kohden Corporation
Decision Date2017-05-19
Product CodeOMA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Nihon Kohden QP-160AK EEG Trend Program 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 2017-05-19 under 510(k) number K163644. The device is classified under product code OMA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nihon Kohden QP-160AK EEG Trend Program?

Nihon Kohden QP-160AK EEG Trend Program is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K163644.

When did Nihon Kohden QP-160AK EEG Trend Program receive FDA 510(k) clearance?

Nihon Kohden QP-160AK EEG Trend Program received FDA 510(k) clearance on 2017-05-19, under 510(k) number K163644.

Who is the listed applicant for Nihon Kohden QP-160AK EEG Trend Program?

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 Nihon Kohden QP-160AK EEG Trend Program?

The FDA product code for Nihon Kohden QP-160AK EEG Trend Program is OMA.

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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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