FDA 510(k)

JAZZ PF

K 號：K191217 · 2019-08-02

決定日期2019-08-02

產品代碼OWI

諮詢委員會或

決定相當於

器材摘要

JAZZ PF is the device name listed in this FDA 510(k) record. The listed applicant is Implanet, S.A.. It received FDA 510(k) clearance on 2019-08-02 under 510(k) number K191217. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the JAZZ PF?

JAZZ PF is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is Implanet, S.A.. The 510(k) number is K191217.

When did JAZZ PF receive FDA 510(k) clearance?

JAZZ PF received FDA 510(k) clearance on 2019-08-02, under 510(k) number K191217.

Who is the listed applicant for JAZZ PF?

The FDA 510(k) record lists Implanet, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAZZ PF?

The FDA product code for JAZZ PF is OWI.

其他以 Implanet, S.A. 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：OWI）

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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