FDA 510(k)

STATIM 6000B 露膠真空滅菌器

K 號：K214057 · 2022-03-31

決定日期2022-03-31

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

STATIM 6000B Vacuum 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 2022-03-31 under 510(k) number K214057. 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 STATIM 6000B Vacuum Autoclave?

STATIM 6000B Vacuum Autoclave is a medical device that received FDA 510(k) clearance on 2022-03-31. The listed applicant is Scican , Ltd.. The 510(k) number is K214057.

When did STATIM 6000B Vacuum Autoclave receive FDA 510(k) clearance?

STATIM 6000B Vacuum Autoclave received FDA 510(k) clearance on 2022-03-31, under 510(k) number K214057.

Who is the listed applicant for STATIM 6000B Vacuum 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 STATIM 6000B Vacuum Autoclave?

The FDA product code for STATIM 6000B Vacuum 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）

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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