FDA 510(k)

NovaGuard SA Pro 安全系統

K 號：K163511 · 2017-02-02

決定日期2017-02-02

產品代碼MEG

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

NovaGuard SA Pro Safety System is the device name listed in this FDA 510(k) record. The listed applicant is West Pharmaceutical Services, Inc.. It received FDA 510(k) clearance on 2017-02-02 under 510(k) number K163511. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NovaGuard SA Pro Safety System?

NovaGuard SA Pro Safety System is a medical device that received FDA 510(k) clearance on 2017-02-02. The listed applicant is West Pharmaceutical Services, Inc.. The 510(k) number is K163511.

When did NovaGuard SA Pro Safety System receive FDA 510(k) clearance?

NovaGuard SA Pro Safety System received FDA 510(k) clearance on 2017-02-02, under 510(k) number K163511.

Who is the listed applicant for NovaGuard SA Pro Safety System?

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

What is the FDA product code for NovaGuard SA Pro Safety System?

The FDA product code for NovaGuard SA Pro Safety System is MEG.

其他以 West Pharmaceutical Services, Inc. 為申請人之記錄

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相關器械（代碼：MEG）

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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