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FDA 510(k)

Fidmi 低配置腸內營養輸送裝置

K 號：K191844 · 2019-09-30

申請人Fidmi Medical, Ltd.
決定日期2019-09-30
產品代碼KGC
諮詢委員會GU
決定相當於

器材摘要

Fidmi Low Profile Enteral Feeding Device is the device name listed in this FDA 510(k) record. The listed applicant is Fidmi Medical, Ltd.. It received FDA 510(k) clearance on 2019-09-30 under 510(k) number K191844. The device is classified under product code KGC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fidmi Low Profile Enteral Feeding Device?

Fidmi Low Profile Enteral Feeding Device is a medical device that received FDA 510(k) clearance on 2019-09-30. The listed applicant is Fidmi Medical, Ltd.. The 510(k) number is K191844.

When did Fidmi Low Profile Enteral Feeding Device receive FDA 510(k) clearance?

Fidmi Low Profile Enteral Feeding Device received FDA 510(k) clearance on 2019-09-30, under 510(k) number K191844.

Who is the listed applicant for Fidmi Low Profile Enteral Feeding Device?

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

What is the FDA product code for Fidmi Low Profile Enteral Feeding Device?

The FDA product code for Fidmi Low Profile Enteral Feeding Device is KGC.

相關臨床試驗

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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相關器械（代碼：KGC）

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。

K242211PUMA-G 小兒系統Coaptech, Inc.K223916PUMA-G 系統Coaptech, Inc.K193612AMT 緝線輸送系統Applied Medical Technology, Inc.K182832Cope兒童腸胃縫合釘組合，造口縫合釘組合Cook IncorporatedK183057PUMA-G 系統Coaptech, LLCK170323Entuit Start 初步放置 胃造口套組Cook Incorporated

官方來源

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