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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 a medical device manufactured by Nihon Kohden Corporation. It received FDA 510(k) clearance on 2016-04-08 under approval 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. It is manufactured by Nihon Kohden Corporation. The 510(k) number is K152305.

When was Nihon Kohden Afib Detection Program QP-039P approved by the FDA?

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

What company makes Nihon Kohden Afib Detection Program QP-039P?

Nihon Kohden Afib Detection Program QP-039P is manufactured by Nihon Kohden Corporation.

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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