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FDA 510(k)

Prosomnus [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

K号: K172859 · 2017-11-22

申请人Prosomnous Sleep Technologies
决定日期2017-11-22
产品代码PLC
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决定实质等同

器械摘要

Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder is the device name listed in this FDA 510(k) record. The listed applicant is Prosomnous Sleep Technologies. It received FDA 510(k) clearance on 2017-11-22 under 510(k) number K172859. 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 Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder?

Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is Prosomnous Sleep Technologies. The 510(k) number is K172859.

When did Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder receive FDA 510(k) clearance?

Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder received FDA 510(k) clearance on 2017-11-22, under 510(k) number K172859.

Who is the listed applicant for Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder?

The FDA 510(k) record lists Prosomnous Sleep Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder?

The FDA product code for Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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.K170606丙烯酸赫斯特矫正器带微型录音器Gergen'S Orthodontic Lab

官方来源

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