FDA 510(k)

AMSCO 600 蒸氣滅菌器

K 號：K232485 · 2023-09-13

申請人Steris

決定日期2023-09-13

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 600 Steam Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Steris. It received FDA 510(k) clearance on 2023-09-13 under 510(k) number K232485. 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 600 Steam Sterilizer?

AMSCO 600 Steam Sterilizer is a medical device that received FDA 510(k) clearance on 2023-09-13. The listed applicant is Steris. The 510(k) number is K232485.

When did AMSCO 600 Steam Sterilizer receive FDA 510(k) clearance?

AMSCO 600 Steam Sterilizer received FDA 510(k) clearance on 2023-09-13, under 510(k) number K232485.

Who is the listed applicant for AMSCO 600 Steam Sterilizer?

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

What is the FDA product code for AMSCO 600 Steam Sterilizer?

The FDA product code for AMSCO 600 Steam Sterilizer is FLE.

其他以 Steris 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。

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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。

K261055AMSCO 700 鋰氣滅菌器STERIS Corporation K260254Enbio PROEnbio Group AG K252307Getinge GSS67N系列蒸氣滅菌器Maquet GmbH (A Getinge Group Company)K250168Life Ultra 25L 桌上單室蒸汽滅菌器Lucas Lifecare K250164卡式蒸汽滅菌器（ACA5）Guangzhou Ajax Medical Equipment Co., Ltd.K243994蒸汽滅菌器（2545D）Ningbo Ican Machines Co., Ltd.

官方來源

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