FDA 510(k)

Rest Assure系统

K号: K233497 · 2024-10-03

决定日期2024-10-03

产品代码PLC

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决定实质等同

器械摘要

Rest Assure System is the device name listed in this FDA 510(k) record. The listed applicant is Somnomed, Inc.. It received FDA 510(k) clearance on 2024-10-03 under 510(k) number K233497. 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 Rest Assure System?

Rest Assure System is a medical device that received FDA 510(k) clearance on 2024-10-03. The listed applicant is Somnomed, Inc.. The 510(k) number is K233497.

When did Rest Assure System receive FDA 510(k) clearance?

Rest Assure System received FDA 510(k) clearance on 2024-10-03, under 510(k) number K233497.

Who is the listed applicant for Rest Assure System?

The FDA 510(k) record lists Somnomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rest Assure System?

The FDA product code for Rest Assure System is PLC.

列明Somnomed, Inc.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。

K261366Virtus K183443SomnoDent Avant K162306SomnoDent ALPHA

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 K252765ProSomnus RPMO2 OSA 设备 (RPMO2 OSA)Prosomnus Sleep Technologies 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

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