FDA 510(k)

JAZZ 吸引閥，JAZZ 空氣/水閥，JAZZ 鐵鎚閥

K 號：K210625 · 2021-09-10

決定日期2021-09-10

產品代碼ODC

諮詢委員會GU

決定相當於

器材摘要

JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medwork GmbH. It received FDA 510(k) clearance on 2021-09-10 under 510(k) number K210625. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve?

JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve is a medical device that received FDA 510(k) clearance on 2021-09-10. The listed applicant is Fujifilm Medwork GmbH. The 510(k) number is K210625.

When did JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve receive FDA 510(k) clearance?

JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve received FDA 510(k) clearance on 2021-09-10, under 510(k) number K210625.

Who is the listed applicant for JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve?

The FDA 510(k) record lists Fujifilm Medwork GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve?

The FDA product code for JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve is ODC.

其他以 Fujifilm Medwork GmbH 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。

K221264FROG 鐵鍵閥 (VAL1-F1-100)

相關器械（代碼：ODC）

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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