FDA 510(k)

VitalFlow™ 主控台

K 號：K230364 · 2023-08-25

申請人Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)

決定日期2023-08-25

產品代碼QNR

諮詢委員會履歷

決定相當於

器材摘要

VitalFlow™ Console is the device name listed in this FDA 510(k) record. The listed applicant is Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.). It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K230364. The device is classified under product code QNR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VitalFlow™ Console?

VitalFlow™ Console is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.). The 510(k) number is K230364.

When did VitalFlow™ Console receive FDA 510(k) clearance?

VitalFlow™ Console received FDA 510(k) clearance on 2023-08-25, under 510(k) number K230364.

Who is the listed applicant for VitalFlow™ Console?

The FDA 510(k) record lists Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitalFlow™ Console?

The FDA product code for VitalFlow™ Console is QNR.

其他以 Michigan Critical Care Consultants, Inc. (D.B.A Mc3 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。

K223898VitalFlow™ 機械式離心泵

相關器械（代碼：QNR）

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。

K250199VitalFlow 控制台Medtronic, Inc.K234118CentriMag™ 急性循環支持系統ABBOTT MEDICAL K233736生命星系系統Cardiacassist, Inc.K223898VitalFlow™ 機械式離心泵Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)K222038CentriMag™ 血液泵，適用於與CentriMag™ 急性循環支持系統使用Abbott (Formerly Thoratec Corporation)K211830生命星系系統Cardiacassist, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。