FDA 510(k)

WEGO-PGA 快速

K 號：K183004 · 2019-01-28

決定日期2019-01-28

產品代碼GAM

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

WEGO-PGA RAPID is the device name listed in this FDA 510(k) record. The listed applicant is Foosin Medical Supplies Inc., Ltd.. It received FDA 510(k) clearance on 2019-01-28 under 510(k) number K183004. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WEGO-PGA RAPID?

WEGO-PGA RAPID is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is Foosin Medical Supplies Inc., Ltd.. The 510(k) number is K183004.

When did WEGO-PGA RAPID receive FDA 510(k) clearance?

WEGO-PGA RAPID received FDA 510(k) clearance on 2019-01-28, under 510(k) number K183004.

Who is the listed applicant for WEGO-PGA RAPID?

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

What is the FDA product code for WEGO-PGA RAPID?

The FDA product code for WEGO-PGA RAPID is GAM.

其他以 Foosin Medical Supplies Inc., Ltd. 為申請人之記錄

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：GAM）

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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