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FDA 510(k)

OASYS 口腔/鼻腔氣道系統及 OASYS Herbst 配戴 Dentitrac 患者監護器

K 號：K181571 · 2019-04-19

申請人Mark Abramson, D.D.S., Inc.
決定日期2019-04-19
產品代碼PLC
諮詢委員會DE
決定相當於

器材摘要

OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Mark Abramson, D.D.S., Inc.. It received FDA 510(k) clearance on 2019-04-19 under 510(k) number K181571. 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 OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor?

OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor is a medical device that received FDA 510(k) clearance on 2019-04-19. The listed applicant is Mark Abramson, D.D.S., Inc.. The 510(k) number is K181571.

When did OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor receive FDA 510(k) clearance?

OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor received FDA 510(k) clearance on 2019-04-19, under 510(k) number K181571.

Who is the listed applicant for OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor?

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

What is the FDA product code for OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor?

The FDA product code for OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor 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 ServicesK172859Prosomnus [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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