FDA 510(k)

MPS2 心肌保護系統控制台

K 號：K173716 · 2018-10-01

決定日期2018-10-01

產品代碼DTR

諮詢委員會履歷

決定相當於

器材摘要

MPS2 Myocardial Protection System Console is the device name listed in this FDA 510(k) record. The listed applicant is Quest Medical, Inc.. It received FDA 510(k) clearance on 2018-10-01 under 510(k) number K173716. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MPS2 Myocardial Protection System Console?

MPS2 Myocardial Protection System Console is a medical device that received FDA 510(k) clearance on 2018-10-01. The listed applicant is Quest Medical, Inc.. The 510(k) number is K173716.

When did MPS2 Myocardial Protection System Console receive FDA 510(k) clearance?

MPS2 Myocardial Protection System Console received FDA 510(k) clearance on 2018-10-01, under 510(k) number K173716.

Who is the listed applicant for MPS2 Myocardial Protection System Console?

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

What is the FDA product code for MPS2 Myocardial Protection System Console?

The FDA product code for MPS2 Myocardial Protection System Console is DTR.

其他以 Quest Medical, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：DTR）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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