FDA 510(k)

ProSomnus RPMO2 OSA 设备 (RPMO2 OSA)

K号: K252765 · 2026-04-06

决定日期2026-04-06

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

ProSomnus RPMO2 OSA Device (RPMO2 OSA) is the device name listed in this FDA 510(k) record. The listed applicant is Prosomnus Sleep Technologies. It received FDA 510(k) clearance on 2026-04-06 under 510(k) number K252765. 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 RPMO2 OSA Device (RPMO2 OSA)?

ProSomnus RPMO2 OSA Device (RPMO2 OSA) is a medical device that received FDA 510(k) clearance on 2026-04-06. The listed applicant is Prosomnus Sleep Technologies. The 510(k) number is K252765.

When did ProSomnus RPMO2 OSA Device (RPMO2 OSA) receive FDA 510(k) clearance?

ProSomnus RPMO2 OSA Device (RPMO2 OSA) received FDA 510(k) clearance on 2026-04-06, under 510(k) number K252765.

Who is the listed applicant for ProSomnus RPMO2 OSA Device (RPMO2 OSA)?

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

What is the FDA product code for ProSomnus RPMO2 OSA Device (RPMO2 OSA)?

The FDA product code for ProSomnus RPMO2 OSA Device (RPMO2 OSA) is PLC.

列明Prosomnus Sleep Technologies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。

K221889ProSomnus EVO [PH] 睡眠和打鼾设备，带患者监测的 ProSomnus EVO [PH] 睡眠和打鼾设备

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, LLC K233497Rest Assure系统Somnomed, Inc.K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services K181571OASYS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 K170606丙烯酸赫斯特矫正器带微型录音器Gergen'S Orthodontic Lab

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。