MicrO2 OSA 设备带微型录音机
K号: K161624 · 2016-11-07
广告
决定日期2016-11-07
产品代码PLC
咨询委员会DE
请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。
决定实质等同
器械摘要
MicrO2 OSA Device with Micro-Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Microdental, Inc.. It received FDA 510(k) clearance on 2016-11-07 under 510(k) number K161624. The device is classified under product code PLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MicrO2 OSA Device with Micro-Recorder?
MicrO2 OSA Device with Micro-Recorder is a medical device that received FDA 510(k) clearance on 2016-11-07. The listed applicant is Microdental, Inc.. The 510(k) number is K161624.
When did MicrO2 OSA Device with Micro-Recorder receive FDA 510(k) clearance?
MicrO2 OSA Device with Micro-Recorder received FDA 510(k) clearance on 2016-11-07, under 510(k) number K161624.
Who is the listed applicant for MicrO2 OSA Device with Micro-Recorder?
The FDA 510(k) record lists Microdental, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MicrO2 OSA Device with Micro-Recorder?
The FDA product code for MicrO2 OSA Device with Micro-Recorder is PLC.
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：PLC）
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。
K254304iNOS口腔生物传感器Achaemenid, LLCK252765ProSomnus RPMO2 OSA 设备 (RPMO2 OSA)Prosomnus Sleep TechnologiesK233497Rest Assure系统Somnomed, Inc.K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep ServicesK181571OASYS口腔/鼻腔气道系统及OASYS Herbst带Dentitrac患者监护仪Mark Abramson, D.D.S., Inc.K172859Prosomnus [CA] 睡眠和打鼾设备以及带有微型录音机的Prosomnus [CA] 睡眠和打鼾设备Prosomnous Sleep Technologies
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。
广告