FDA 510(k)

蟲蛙微輸注裝置

K 號：K153501 · 2016-04-15

決定日期2016-04-15

產品代碼KRA

諮詢委員會履歷

決定相當於

器材摘要

Bullfrog Micro-Infusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Mercator Medsystems, Inc.. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K153501. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bullfrog Micro-Infusion Device?

Bullfrog Micro-Infusion Device is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Mercator Medsystems, Inc.. The 510(k) number is K153501.

When did Bullfrog Micro-Infusion Device receive FDA 510(k) clearance?

Bullfrog Micro-Infusion Device received FDA 510(k) clearance on 2016-04-15, under 510(k) number K153501.

Who is the listed applicant for Bullfrog Micro-Infusion Device?

The FDA 510(k) record lists Mercator Medsystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bullfrog Micro-Infusion Device?

The FDA product code for Bullfrog Micro-Infusion Device is KRA.

其他以 Mercator Medsystems, Inc. 為申請人之記錄

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相關器械（代碼：KRA）

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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