FDA 510(k)

量子泵控制台

K 號：K173834 · 2018-05-25

決定日期2018-05-25

產品代碼DTQ

諮詢委員會履歷

決定相當於

器材摘要

Quantum Pump Console 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 2018-05-25 under 510(k) number K173834. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quantum Pump Console?

Quantum Pump Console is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K173834.

When did Quantum Pump Console receive FDA 510(k) clearance?

Quantum Pump Console received FDA 510(k) clearance on 2018-05-25, under 510(k) number K173834.

Who is the listed applicant for Quantum Pump Console?

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 Quantum Pump Console?

The FDA product code for Quantum Pump Console is DTQ.

其他以 Spectrum Medical , Ltd. 為申請人之記錄

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相關器械（代碼：DTQ）

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。

K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH K221895特魯美先進灌流系統 1Terumo Cardiovascular Systems Corporation K221373Essenz HLMLivanova Deutschland, GmbH K210130Stockert S5 系統Livanova Deutschland, GmbH K202125世紀灌流系統Century Hlm, LLC K190282量子智慧閉塞器 LH（左手），量子智慧閉塞器 LH（右手）Spectrum Medical , Ltd.

官方來源

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