FDA 510(k)

Genesis低温可重复使用刚性容器系统

K号: K153554 · 2016-03-21

决定日期2016-03-21

产品代码KCT

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

Genesis Low Temperature Reusable Rigid Container System is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 2200, Inc.. It received FDA 510(k) clearance on 2016-03-21 under 510(k) number K153554. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Genesis Low Temperature Reusable Rigid Container System?

Genesis Low Temperature Reusable Rigid Container System is a medical device that received FDA 510(k) clearance on 2016-03-21. The listed applicant is Carefusion 2200, Inc.. The 510(k) number is K153554.

When did Genesis Low Temperature Reusable Rigid Container System receive FDA 510(k) clearance?

Genesis Low Temperature Reusable Rigid Container System received FDA 510(k) clearance on 2016-03-21, under 510(k) number K153554.

Who is the listed applicant for Genesis Low Temperature Reusable Rigid Container System?

The FDA 510(k) record lists Carefusion 2200, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Genesis Low Temperature Reusable Rigid Container System?

The FDA product code for Genesis Low Temperature Reusable Rigid Container System is KCT.

列明Carefusion 2200, 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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