FDA 510(k)

醫療設備名稱：CARDIOSKIN

K 號：K173248 · 2018-08-11

決定日期2018-08-11

產品代碼DXH

諮詢委員會履歷

決定相當於

器材摘要

CARDIOSKIN is the device name listed in this FDA 510(k) record. The listed applicant is Bioserenity Sas. It received FDA 510(k) clearance on 2018-08-11 under 510(k) number K173248. 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 CARDIOSKIN?

CARDIOSKIN is a medical device that received FDA 510(k) clearance on 2018-08-11. The listed applicant is Bioserenity Sas. The 510(k) number is K173248.

When did CARDIOSKIN receive FDA 510(k) clearance?

CARDIOSKIN received FDA 510(k) clearance on 2018-08-11, under 510(k) number K173248.

Who is the listed applicant for CARDIOSKIN?

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

What is the FDA product code for CARDIOSKIN?

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

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