FDA 510(k)

防護套管

K 號：K191448 · 2019-10-08

決定日期2019-10-08

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

Barrier Sleeves is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2019-10-08 under 510(k) number K191448. 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 Barrier Sleeves?

Barrier Sleeves is a medical device that received FDA 510(k) clearance on 2019-10-08. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K191448.

When did Barrier Sleeves receive FDA 510(k) clearance?

Barrier Sleeves received FDA 510(k) clearance on 2019-10-08, under 510(k) number K191448.

Who is the listed applicant for Barrier Sleeves?

The FDA 510(k) record lists Ivoclar Vivadent, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Barrier Sleeves?

The FDA product code for Barrier Sleeves is PEM.

其他以 Ivoclar Vivadent, AG 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：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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