FDA 510(k)

Anivia SG1000 泵控制台

K 號：K230698 · 2023-04-18

決定日期2023-04-18

產品代碼DWA

諮詢委員會履歷

決定相當於

器材摘要

Anivia SG1000 Pump Console is the device name listed in this FDA 510(k) record. The listed applicant is Apmtd, Inc.. It received FDA 510(k) clearance on 2023-04-18 under 510(k) number K230698. 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 Anivia SG1000 Pump Console?

Anivia SG1000 Pump Console is a medical device that received FDA 510(k) clearance on 2023-04-18. The listed applicant is Apmtd, Inc.. The 510(k) number is K230698.

When did Anivia SG1000 Pump Console receive FDA 510(k) clearance?

Anivia SG1000 Pump Console received FDA 510(k) clearance on 2023-04-18, under 510(k) number K230698.

Who is the listed applicant for Anivia SG1000 Pump Console?

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

What is the FDA product code for Anivia SG1000 Pump Console?

The FDA product code for Anivia SG1000 Pump Console is DWA.

其他以 Apmtd, Inc. 為申請人之記錄

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K221491Anivia SG1000 泵控制台

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.K221491Anivia SG1000 泵控制台Apmtd, Inc.K192838量子離心驅動-高壓，量子離心驅動-中壓Spectrum Medical , Ltd.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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