FDA 510(k)

三角形系統

K 號：K183319 · 2019-05-10

決定日期2019-05-10

產品代碼DXH

諮詢委員會履歷

決定相當於

器材摘要

Triangle System is the device name listed in this FDA 510(k) record. The listed applicant is AliveCor, Inc.. It received FDA 510(k) clearance on 2019-05-10 under 510(k) number K183319. 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 Triangle System?

Triangle System is a medical device that received FDA 510(k) clearance on 2019-05-10. The listed applicant is AliveCor, Inc.. The 510(k) number is K183319.

When did Triangle System receive FDA 510(k) clearance?

Triangle System received FDA 510(k) clearance on 2019-05-10, under 510(k) number K183319.

Who is the listed applicant for Triangle System?

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

What is the FDA product code for Triangle System?

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

其他以 AliveCor, Inc. 為申請人之記錄

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