FDA 510(k)

STATClave G4 蒸汽壓力殺菌器

K 號：K192910 · 2020-06-19

決定日期2020-06-19

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

STATClave G4 Chamber Autoclave is the device name listed in this FDA 510(k) record. The listed applicant is Scican , Ltd.. It received FDA 510(k) clearance on 2020-06-19 under 510(k) number K192910. 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 STATClave G4 Chamber Autoclave?

STATClave G4 Chamber Autoclave is a medical device that received FDA 510(k) clearance on 2020-06-19. The listed applicant is Scican , Ltd.. The 510(k) number is K192910.

When did STATClave G4 Chamber Autoclave receive FDA 510(k) clearance?

STATClave G4 Chamber Autoclave received FDA 510(k) clearance on 2020-06-19, under 510(k) number K192910.

Who is the listed applicant for STATClave G4 Chamber Autoclave?

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

What is the FDA product code for STATClave G4 Chamber Autoclave?

The FDA product code for STATClave G4 Chamber Autoclave is FLE.

其他以 Scican , Ltd. 為申請人之記錄

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相關器械（代碼：FLE）

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官方來源

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