FDA 510(k)

GelPOINT Mini 高級進入平台

K 號：K191866 · 2020-04-29

決定日期2020-04-29

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

GelPOINT Mini Advanced Access Platform is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical. It received FDA 510(k) clearance on 2020-04-29 under 510(k) number K191866. 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 GelPOINT Mini Advanced Access Platform?

GelPOINT Mini Advanced Access Platform is a medical device that received FDA 510(k) clearance on 2020-04-29. The listed applicant is Applied Medical. The 510(k) number is K191866.

When did GelPOINT Mini Advanced Access Platform receive FDA 510(k) clearance?

GelPOINT Mini Advanced Access Platform received FDA 510(k) clearance on 2020-04-29, under 510(k) number K191866.

Who is the listed applicant for GelPOINT Mini Advanced Access Platform?

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

What is the FDA product code for GelPOINT Mini Advanced Access Platform?

The FDA product code for GelPOINT Mini Advanced Access Platform is GCJ.

其他以 Applied Medical 為申請人之記錄

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相關器械（代碼：GCJ）

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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官方來源

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