FDA 510(k)

優級加值一次性防護袖套

K 號：K163447 · 2017-06-20

決定日期2017-06-20

產品代碼PEM

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

Premium Plus Disposable Barrier Sleeve is the device name listed in this FDA 510(k) record. The listed applicant is Premium Plus International Limited. It received FDA 510(k) clearance on 2017-06-20 under 510(k) number K163447. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Premium Plus Disposable Barrier Sleeve?

Premium Plus Disposable Barrier Sleeve is a medical device that received FDA 510(k) clearance on 2017-06-20. The listed applicant is Premium Plus International Limited. The 510(k) number is K163447.

When did Premium Plus Disposable Barrier Sleeve receive FDA 510(k) clearance?

Premium Plus Disposable Barrier Sleeve received FDA 510(k) clearance on 2017-06-20, under 510(k) number K163447.

Who is the listed applicant for Premium Plus Disposable Barrier Sleeve?

The FDA 510(k) record lists Premium Plus International Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Premium Plus Disposable Barrier Sleeve?

The FDA product code for Premium Plus Disposable Barrier Sleeve is PEM.

其他以 Premium Plus International Limited 為申請人之記錄

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相關器械（代碼：PEM）

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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