FDA 510(k)

貝麥德蒸氣消毒器 MST-H TOP 5000

K 號：K170228 · 2017-05-12

決定日期2017-05-12

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

Belimed Steam Sterilizer MST-H TOP 5000 is the device name listed in this FDA 510(k) record. The listed applicant is Belimed AG. It received FDA 510(k) clearance on 2017-05-12 under 510(k) number K170228. 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 Belimed Steam Sterilizer MST-H TOP 5000?

Belimed Steam Sterilizer MST-H TOP 5000 is a medical device that received FDA 510(k) clearance on 2017-05-12. The listed applicant is Belimed AG. The 510(k) number is K170228.

When did Belimed Steam Sterilizer MST-H TOP 5000 receive FDA 510(k) clearance?

Belimed Steam Sterilizer MST-H TOP 5000 received FDA 510(k) clearance on 2017-05-12, under 510(k) number K170228.

Who is the listed applicant for Belimed Steam Sterilizer MST-H TOP 5000?

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

What is the FDA product code for Belimed Steam Sterilizer MST-H TOP 5000?

The FDA product code for Belimed Steam Sterilizer MST-H TOP 5000 is FLE.

其他以 Belimed AG 為申請人之記錄

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K191896貝麥德蒸氣消毒器 MST-H TOP 5000

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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