FDA 510(k)

Aspire 机械吸引器 G

K号: K200629 · 2020-05-29

决定日期2020-05-29

产品代码FMF

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Control Medical Technology为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K200871Aspire MAX 7 - 11F 机械血栓切除术系统和Aspire 机械吸引器

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关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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