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FDA 510(k)

Alpha Pure

K-Number: K163117 · 2017-05-09

ApplicantKoroad America
Decision Date2017-05-09
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Alpha Pure is a medical device manufactured by Koroad America. It received FDA 510(k) clearance on 2017-05-09 under approval number K163117. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alpha Pure?

Alpha Pure is a medical device that received FDA 510(k) clearance on 2017-05-09. It is manufactured by Koroad America. The 510(k) number is K163117.

When was Alpha Pure approved by the FDA?

Alpha Pure received FDA 510(k) clearance on 2017-05-09, under approval number K163117.

What company makes Alpha Pure?

Alpha Pure is manufactured by Koroad America.

What is the FDA product code for Alpha Pure?

The FDA product code for Alpha Pure is NJM.

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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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