FDA 510(k)

Celerity ECG 电缆附件包

K号: K171931 · 2017-10-26

决定日期2017-10-26

产品代码LJS

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

Celerity ECG Cable Accessory Pack is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp (Medical Components, Inc.). It received FDA 510(k) clearance on 2017-10-26 under 510(k) number K171931. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Celerity ECG Cable Accessory Pack?

Celerity ECG Cable Accessory Pack is a medical device that received FDA 510(k) clearance on 2017-10-26. The listed applicant is Medcomp (Medical Components, Inc.). The 510(k) number is K171931.

When did Celerity ECG Cable Accessory Pack receive FDA 510(k) clearance?

Celerity ECG Cable Accessory Pack received FDA 510(k) clearance on 2017-10-26, under 510(k) number K171931.

Who is the listed applicant for Celerity ECG Cable Accessory Pack?

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

What is the FDA product code for Celerity ECG Cable Accessory Pack?

The FDA product code for Celerity ECG Cable Accessory Pack is LJS.

列明Medcomp (Medical Components, Inc.)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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相关器械（代码：LJS）

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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