Polysmith 睡眠系统，型号 NTI7593
K号: K161650 · 2017-01-19
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决定日期2017-01-19
产品代码OLV
咨询委员会NE
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器械摘要
Polysmith Sleep System, Model NTI7593 is the device name listed in this FDA 510(k) record. The listed applicant is Neurotronics, Inc.. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K161650. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Polysmith Sleep System, Model NTI7593?
Polysmith Sleep System, Model NTI7593 is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Neurotronics, Inc.. The 510(k) number is K161650.
When did Polysmith Sleep System, Model NTI7593 receive FDA 510(k) clearance?
Polysmith Sleep System, Model NTI7593 received FDA 510(k) clearance on 2017-01-19, under 510(k) number K161650.
Who is the listed applicant for Polysmith Sleep System, Model NTI7593?
The FDA 510(k) record lists Neurotronics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Polysmith Sleep System, Model NTI7593?
The FDA product code for Polysmith Sleep System, Model NTI7593 is OLV.
相关临床试验
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列明Neurotronics, Inc.为申报人的其他记录
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相关器械（代码：OLV）
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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