FDA 510(k)

Aspire 體外吸引器 G

K 號：K200629 · 2020-05-29

決定日期2020-05-29

產品代碼FMF

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

Aspire Mechanical Aspirator G is the device name listed in this FDA 510(k) record. The listed applicant is Control Medical Technology. It received FDA 510(k) clearance on 2020-05-29 under 510(k) number K200629. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aspire Mechanical Aspirator G?

Aspire Mechanical Aspirator G is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is Control Medical Technology. The 510(k) number is K200629.

When did Aspire Mechanical Aspirator G receive FDA 510(k) clearance?

Aspire Mechanical Aspirator G received FDA 510(k) clearance on 2020-05-29, under 510(k) number K200629.

Who is the listed applicant for Aspire Mechanical Aspirator G?

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

What is the FDA product code for Aspire Mechanical Aspirator G?

The FDA product code for Aspire Mechanical Aspirator G is FMF.

其他以 Control Medical Technology 為申請人之記錄

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官方來源

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