FDA 510(k)

紅寶石流耦合系統

K 號：K190499 · 2019-09-06

申請人Baxter/ Synovis Micro Companies Alliance, Inc.

決定日期2019-09-06

產品代碼MVR

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Gem FlowCoupler System is the device name listed in this FDA 510(k) record. The listed applicant is Baxter/ Synovis Micro Companies Alliance, Inc.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K190499. The device is classified under product code MVR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Gem FlowCoupler System?

Gem FlowCoupler System is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Baxter/ Synovis Micro Companies Alliance, Inc.. The 510(k) number is K190499.

When did Gem FlowCoupler System receive FDA 510(k) clearance?

Gem FlowCoupler System received FDA 510(k) clearance on 2019-09-06, under 510(k) number K190499.

Who is the listed applicant for Gem FlowCoupler System?

The FDA 510(k) record lists Baxter/ Synovis Micro Companies Alliance, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gem FlowCoupler System?

The FDA product code for Gem FlowCoupler System is MVR.

其他以 Baxter/ Synovis Micro Companies Alliance, Inc. 為申請人之記錄

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K191252紅寶石流耦合系統

相關器械（代碼：MVR）

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。

K191252紅寶石流耦合系統Baxter/ Synovis Micro Companies Alliance, Inc.

官方來源

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