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FDA 510(k)

Bfit Sleep，Bfit Sleep 配 DentiTrac，Bfit Engage，Bfit Engage 配 DentiTrac

K 號：K190353 · 2020-04-10

申請人Residential Home Sleep Services
決定日期2020-04-10
產品代碼PLC
諮詢委員會DE
決定相當於

器材摘要

Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac is the device name listed in this FDA 510(k) record. The listed applicant is Residential Home Sleep Services. It received FDA 510(k) clearance on 2020-04-10 under 510(k) number K190353. 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 Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac?

Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac is a medical device that received FDA 510(k) clearance on 2020-04-10. The listed applicant is Residential Home Sleep Services. The 510(k) number is K190353.

When did Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac receive FDA 510(k) clearance?

Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac received FDA 510(k) clearance on 2020-04-10, under 510(k) number K190353.

Who is the listed applicant for Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac?

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

What is the FDA product code for Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac?

The FDA product code for Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac 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.K181571OASYS 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.K172859Prosomnus [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Prosomnous Sleep TechnologiesK170606Acrylic Herbst Appliance with Micro-RecorderGergen'S Orthodontic Lab

官方來源

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