SimulCare II™
K号: K160246 · 2016-10-06
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决定日期2016-10-06
产品代码GZJ
咨询委员会NE
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器械摘要
SimulCare II(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Xanacare Technologies, LLC. It received FDA 510(k) clearance on 2016-10-06 under 510(k) number K160246. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SimulCare II(TM)?
SimulCare II(TM) is a medical device that received FDA 510(k) clearance on 2016-10-06. The listed applicant is Xanacare Technologies, LLC. The 510(k) number is K160246.
When did SimulCare II(TM) receive FDA 510(k) clearance?
SimulCare II(TM) received FDA 510(k) clearance on 2016-10-06, under 510(k) number K160246.
Who is the listed applicant for SimulCare II(TM)?
The FDA 510(k) record lists Xanacare Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SimulCare II(TM)?
The FDA product code for SimulCare II(TM) is GZJ.
相关临床试验
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相关器械（代码：GZJ）
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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