FDA 510(k)

普里茲瑪

K 號：K173589 · 2018-11-30

決定日期2018-11-30

產品代碼DXH

諮詢委員會履歷

決定相當於

器材摘要

Prizma is the device name listed in this FDA 510(k) record. The listed applicant is G-Medical Innovations , Ltd.. It received FDA 510(k) clearance on 2018-11-30 under 510(k) number K173589. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Prizma?

Prizma is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is G-Medical Innovations , Ltd.. The 510(k) number is K173589.

When did Prizma receive FDA 510(k) clearance?

Prizma received FDA 510(k) clearance on 2018-11-30, under 510(k) number K173589.

Who is the listed applicant for Prizma?

The FDA 510(k) record lists G-Medical Innovations , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prizma?

The FDA product code for Prizma is DXH. This falls under the Hematology category.

其他以 G-Medical Innovations , Ltd. 為申請人之記錄

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K170181普里茲瑪

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