FDA 510(k)

デンフォーフジフィルム 700 単回使用清掃アダプター

K番号: K250140 · 2025-02-20

決定日2025-02-20

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Substantially Equivalent

医療機器の概要

Defendo Fujifilm 700 Single Use Cleaning Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Steris Corparation. It received FDA 510(k) clearance on 2025-02-20 under 510(k) number K250140. 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 Defendo Fujifilm 700 Single Use Cleaning Adapter?

Defendo Fujifilm 700 Single Use Cleaning Adapter is a medical device that received FDA 510(k) clearance on 2025-02-20. The listed applicant is Steris Corparation. The 510(k) number is K250140.

When did Defendo Fujifilm 700 Single Use Cleaning Adapter receive FDA 510(k) clearance?

Defendo Fujifilm 700 Single Use Cleaning Adapter received FDA 510(k) clearance on 2025-02-20, under 510(k) number K250140.

Who is the listed applicant for Defendo Fujifilm 700 Single Use Cleaning Adapter?

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

What is the FDA product code for Defendo Fujifilm 700 Single Use Cleaning Adapter?

The FDA product code for Defendo Fujifilm 700 Single Use Cleaning Adapter is ODC.

申請者としてSteris Corparationを記載するその他の記録

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