FDA 510(k)

Alpha Pure

K-번호: K163117 · 2017-05-09

결정일2017-05-09

제품 코드NJM

자문 위원회DE

결정Substantially Equivalent

기기 요약

Alpha Pure is the device name listed in this FDA 510(k) record. The listed applicant is Koroad America. It received FDA 510(k) clearance on 2017-05-09 under 510(k) number K163117. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Alpha Pure?

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

When did Alpha Pure receive FDA 510(k) clearance?

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

Who is the listed applicant for Alpha Pure?

The FDA 510(k) record lists Koroad America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alpha Pure?

The FDA product code for Alpha Pure is NJM.

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Alpha Pure

기기 요약

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관련 임상시험

관련 기기 (코드: NJM)

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