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FDA 510(k)

Prosomnus [CA] 睡眠和打鼾設備以及帶有微型錄音器的Prosomnus [CA] 睡眠和打鼾設備

K 號：K172859 · 2017-11-22

申請人Prosomnous Sleep Technologies
決定日期2017-11-22
產品代碼PLC
諮詢委員會DE
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：PLC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254304iNOS口腔生物感測器Achaemenid, LLCK252765ProSomnus RPMO2 OSA 裝置（RPMO2 OSA）Prosomnus Sleep TechnologiesK233497安心系統Somnomed, Inc.K190353Bfit Sleep，Bfit Sleep 配 DentiTrac，Bfit Engage，Bfit Engage 配 DentiTracResidential Home Sleep ServicesK181571OASYS 口腔/鼻腔氣道系統及 OASYS Herbst 配戴 Dentitrac 患者監護器Mark Abramson, D.D.S., Inc.K170606Acrylic Herbst Appliance with Micro-RecorderGergen'S Orthodontic Lab

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