ISEN-护目镜带数据查看器
K号: K163270 · 2017-09-25
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决定日期2017-09-25
产品代码GWN
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
ISEN-Goggles with Data Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Isent Tech & Trading Company, Ltd.. It received FDA 510(k) clearance on 2017-09-25 under 510(k) number K163270. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ISEN-Goggles with Data Viewer?
ISEN-Goggles with Data Viewer is a medical device that received FDA 510(k) clearance on 2017-09-25. The listed applicant is Isent Tech & Trading Company, Ltd.. The 510(k) number is K163270.
When did ISEN-Goggles with Data Viewer receive FDA 510(k) clearance?
ISEN-Goggles with Data Viewer received FDA 510(k) clearance on 2017-09-25, under 510(k) number K163270.
Who is the listed applicant for ISEN-Goggles with Data Viewer?
The FDA 510(k) record lists Isent Tech & Trading Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ISEN-Goggles with Data Viewer?
The FDA product code for ISEN-Goggles with Data Viewer is GWN.
相关临床试验
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：GWN）
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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