FDA 510(k)

鋼鐵公司VS系列蒸汽滅菌器，型號262839、262851、262869

K 號：K213545 · 2023-02-02

決定日期2023-02-02

產品代碼FLE

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 is the device name listed in this FDA 510(k) record. The listed applicant is Steelco S.P.A.. It received FDA 510(k) clearance on 2023-02-02 under 510(k) number K213545. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869?

Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 is a medical device that received FDA 510(k) clearance on 2023-02-02. The listed applicant is Steelco S.P.A.. The 510(k) number is K213545.

When did Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 receive FDA 510(k) clearance?

Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 received FDA 510(k) clearance on 2023-02-02, under 510(k) number K213545.

Who is the listed applicant for Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869?

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

What is the FDA product code for Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869?

The FDA product code for Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 is FLE.

相關器械（代碼：FLE）

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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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：FLE）

官方來源