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FDA 510(k)

OASYS口腔/鼻腔气道系统及OASYS Herbst带Dentitrac患者监护仪

K号: K181571 · 2019-04-19

申请人Mark Abramson, D.D.S., Inc.
决定日期2019-04-19
产品代码PLC
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决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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, LLCK252765ProSomnus RPMO2 OSA 设备 (RPMO2 OSA)Prosomnus Sleep TechnologiesK233497Rest Assure系统Somnomed, Inc.K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep ServicesK172859Prosomnus [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 TechnologiesK170606丙烯酸赫斯特矫正器带微型录音器Gergen'S Orthodontic Lab

官方来源

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