Cerebra 睡眠系统
K号: K213007 · 2022-07-06
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决定日期2022-07-06
产品代码OLV
咨询委员会NE
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器械摘要
Cerebra Sleep System is the device name listed in this FDA 510(k) record. The listed applicant is Cerebra Medical , Ltd.. It received FDA 510(k) clearance on 2022-07-06 under 510(k) number K213007. 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 Cerebra Sleep System?
Cerebra Sleep System is a medical device that received FDA 510(k) clearance on 2022-07-06. The listed applicant is Cerebra Medical , Ltd.. The 510(k) number is K213007.
When did Cerebra Sleep System receive FDA 510(k) clearance?
Cerebra Sleep System received FDA 510(k) clearance on 2022-07-06, under 510(k) number K213007.
Who is the listed applicant for Cerebra Sleep System?
The FDA 510(k) record lists Cerebra Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cerebra Sleep System?
The FDA product code for Cerebra Sleep System is OLV.
相关临床试验
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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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