FDA 510(k)

EASYGRIP FLO-41精準MIS輸送系統

K 號：K193137 · 2020-01-08

決定日期2020-01-08

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

EASYGRIP FLO-41 Precision MIS Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corportation. It received FDA 510(k) clearance on 2020-01-08 under 510(k) number K193137. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EASYGRIP FLO-41 Precision MIS Delivery System?

EASYGRIP FLO-41 Precision MIS Delivery System is a medical device that received FDA 510(k) clearance on 2020-01-08. The listed applicant is Baxter Healthcare Corportation. The 510(k) number is K193137.

When did EASYGRIP FLO-41 Precision MIS Delivery System receive FDA 510(k) clearance?

EASYGRIP FLO-41 Precision MIS Delivery System received FDA 510(k) clearance on 2020-01-08, under 510(k) number K193137.

Who is the listed applicant for EASYGRIP FLO-41 Precision MIS Delivery System?

The FDA 510(k) record lists Baxter Healthcare Corportation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASYGRIP FLO-41 Precision MIS Delivery System?

The FDA product code for EASYGRIP FLO-41 Precision MIS Delivery System is GCJ.

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相關器械（代碼：GCJ）

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官方來源

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