FDA 510(k)

FloPump 57mL 鼓風泵

K 號：K193663 · 2021-03-10

決定日期2021-03-10

產品代碼KFM

諮詢委員會履歷

決定相當於

器材摘要

FloPump 57mL Centrifugal Pump is the device name listed in this FDA 510(k) record. The listed applicant is International Biophysics Corporation. It received FDA 510(k) clearance on 2021-03-10 under 510(k) number K193663. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FloPump 57mL Centrifugal Pump?

FloPump 57mL Centrifugal Pump is a medical device that received FDA 510(k) clearance on 2021-03-10. The listed applicant is International Biophysics Corporation. The 510(k) number is K193663.

When did FloPump 57mL Centrifugal Pump receive FDA 510(k) clearance?

FloPump 57mL Centrifugal Pump received FDA 510(k) clearance on 2021-03-10, under 510(k) number K193663.

Who is the listed applicant for FloPump 57mL Centrifugal Pump?

The FDA 510(k) record lists International Biophysics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FloPump 57mL Centrifugal Pump?

The FDA product code for FloPump 57mL Centrifugal Pump is KFM.

其他以 International Biophysics Corporation 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。

K170029FloPump 32mL，无菌，FloPump 32mL，非无菌

相關器械（代碼：KFM）

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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