SleepImage系统
K号: K182618 · 2019-08-14
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决定日期2019-08-14
产品代码MNR
咨询委员会AN
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器械摘要
SleepImage System is the device name listed in this FDA 510(k) record. The listed applicant is Mycardio, LLC Dba Sleepimage.. It received FDA 510(k) clearance on 2019-08-14 under 510(k) number K182618. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SleepImage System?
SleepImage System is a medical device that received FDA 510(k) clearance on 2019-08-14. The listed applicant is Mycardio, LLC Dba Sleepimage.. The 510(k) number is K182618.
When did SleepImage System receive FDA 510(k) clearance?
SleepImage System received FDA 510(k) clearance on 2019-08-14, under 510(k) number K182618.
Who is the listed applicant for SleepImage System?
The FDA 510(k) record lists Mycardio, LLC Dba Sleepimage. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SleepImage System?
The FDA product code for SleepImage System is MNR.
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。
列明Mycardio, LLC Dba Sleepimage.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：MNR）
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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