FDA 510(k)

量子離心驅動-高壓，量子離心驅動-中壓

K 號：K192838 · 2020-04-13

決定日期2020-04-13

產品代碼DWA

諮詢委員會履歷

決定相當於

器材摘要

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2020-04-13 under 510(k) number K192838. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure?

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure is a medical device that received FDA 510(k) clearance on 2020-04-13. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K192838.

When did Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure receive FDA 510(k) clearance?

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure received FDA 510(k) clearance on 2020-04-13, under 510(k) number K192838.

Who is the listed applicant for Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure?

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

What is the FDA product code for Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure?

The FDA product code for Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure is DWA.

其他以 Spectrum Medical , Ltd. 為申請人之記錄

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相關器械（代碼：DWA）

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。

K232788INSPiRA ART100Inspira Technologies Oxy B.H.N. , Ltd.K230698Anivia SG1000 泵控制台Apmtd, Inc.K221491Anivia SG1000 泵控制台Apmtd, Inc.K200306CentriMag 循環輔助系統，CentriMag 返流（動脈）針管套件，CentriMag 排液（靜脈）針管套件Abbott (Formerly Thoratec Corporation)K191557CentriMag 急性循環支持系統Thoratec Corporation (Now Part of Abbott)

官方來源

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