FDA 510(k)

MPXA-2000

K 號：K222036 · 2023-03-22

決定日期2023-03-22

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

MPXA-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Medipixel, Inc.. It received FDA 510(k) clearance on 2023-03-22 under 510(k) number K222036. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MPXA-2000?

MPXA-2000 is a medical device that received FDA 510(k) clearance on 2023-03-22. The listed applicant is Medipixel, Inc.. The 510(k) number is K222036.

When did MPXA-2000 receive FDA 510(k) clearance?

MPXA-2000 received FDA 510(k) clearance on 2023-03-22, under 510(k) number K222036.

Who is the listed applicant for MPXA-2000?

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

What is the FDA product code for MPXA-2000?

The FDA product code for MPXA-2000 is QIH.

相關器械（代碼：QIH）

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官方來源

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