FDA 510(k)

JAZZ吸引弁、JAZZ空気/水弁、JAZZ検出弁

K番号: K210625 · 2021-09-10

決定日2021-09-10

製品コードODC

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてFujifilm Medwork GmbHを記載するその他の記録

K221264FROGフォースプスバルブ（VAL1-F1-100）

公式ソース

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