FDA 510(k)

AMSCO 700 鋰氣滅菌器

K 號：K261055 · 2026-06-24

決定日期2026-06-24

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

AMSCO 700 Steam Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2026-06-24 under 510(k) number K261055. 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 AMSCO 700 Steam Sterilizer?

AMSCO 700 Steam Sterilizer is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is STERIS Corporation. The 510(k) number is K261055.

When did AMSCO 700 Steam Sterilizer receive FDA 510(k) clearance?

AMSCO 700 Steam Sterilizer received FDA 510(k) clearance on 2026-06-24, under 510(k) number K261055.

Who is the listed applicant for AMSCO 700 Steam Sterilizer?

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

What is the FDA product code for AMSCO 700 Steam Sterilizer?

The FDA product code for AMSCO 700 Steam Sterilizer is FLE.

其他以 STERIS Corporation 為申請人之記錄

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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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