Trex_HD
K号: K162595 · 2016-11-04
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决定日期2016-11-04
产品代码GWQ
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Trex_HD is the device name listed in this FDA 510(k) record. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K162595. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Trex_HD?
Trex_HD is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K162595.
When did Trex_HD receive FDA 510(k) clearance?
Trex_HD received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162595.
Who is the listed applicant for Trex_HD?
The FDA 510(k) record lists Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Trex_HD?
The FDA product code for Trex_HD is GWQ.
列明Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)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。
相关器械（代码：GWQ）
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。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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