FDA 510(k)

SwabTip Male Disinfectant Cap

K号: K190918 · 2020-03-06

决定日期2020-03-06

产品代码QBP

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

SwabTip Male Disinfectant Cap is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical. It received FDA 510(k) clearance on 2020-03-06 under 510(k) number K190918. The device is classified under product code QBP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SwabTip Male Disinfectant Cap?

SwabTip Male Disinfectant Cap is a medical device that received FDA 510(k) clearance on 2020-03-06. The listed applicant is Icu Medical. The 510(k) number is K190918.

When did SwabTip Male Disinfectant Cap receive FDA 510(k) clearance?

SwabTip Male Disinfectant Cap received FDA 510(k) clearance on 2020-03-06, under 510(k) number K190918.

Who is the listed applicant for SwabTip Male Disinfectant Cap?

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

What is the FDA product code for SwabTip Male Disinfectant Cap?

The FDA product code for SwabTip Male Disinfectant Cap is QBP.

列明Icu Medical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。

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