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FDA 510(k)

Nihon Kohden Afib Detection Program QP-039P

K-Number: K152305 · 2016-04-08

ApplicantNihon Kohden Corporation
Decision Date2016-04-08
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Nihon Kohden Afib Detection Program QP-039P 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 2016-04-08 under 510(k) number K152305. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nihon Kohden Afib Detection Program QP-039P?

Nihon Kohden Afib Detection Program QP-039P is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K152305.

When did Nihon Kohden Afib Detection Program QP-039P receive FDA 510(k) clearance?

Nihon Kohden Afib Detection Program QP-039P received FDA 510(k) clearance on 2016-04-08, under 510(k) number K152305.

Who is the listed applicant for Nihon Kohden Afib Detection Program QP-039P?

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 Afib Detection Program QP-039P?

The FDA product code for Nihon Kohden Afib Detection Program QP-039P is DSI.

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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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