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FDA 510(k)

Sunset加热CPAP管

K号: K201418 · 2021-01-29

申请人Sunset Healthcare Solutions, Inc.
决定日期2021-01-29
产品代码BZE
咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同

器械摘要

Sunset Heated CPAP Tube is the device name listed in this FDA 510(k) record. The listed applicant is Sunset Healthcare Solutions, Inc.. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K201418. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sunset Heated CPAP Tube?

Sunset Heated CPAP Tube is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Sunset Healthcare Solutions, Inc.. The 510(k) number is K201418.

When did Sunset Heated CPAP Tube receive FDA 510(k) clearance?

Sunset Heated CPAP Tube received FDA 510(k) clearance on 2021-01-29, under 510(k) number K201418.

Who is the listed applicant for Sunset Heated CPAP Tube?

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

What is the FDA product code for Sunset Heated CPAP Tube?

The FDA product code for Sunset Heated CPAP Tube is BZE.

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：BZE）

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。

K252066inspired™ 加热呼吸回路（510-008）；inspired™ 加热呼吸回路（510-009）；inspired™ 自动进料加湿室（VHC10）；inspired™ 自动进料加湿室（VHC20）Vincent Healthcare Products LimitedK253322Hudson RCI® 婴儿Dri-TechTM 呼吸回路（HUD99060 / Dri-Tech 婴儿回路，HUD99060KIT / Dri-Tech 婴儿回路套件，HUD99001KIT / 单肢婴儿回路Dri-Tech 套件，HUD99009KIT / Dri-Tech 婴儿回路套件，HUD99018KIT / Dri-Tech 婴儿回路套件，HUD870NKIT / Dri-Tech 婴儿附件袋，HUD1631 / 婴儿Y型连接器带旋转接头）Medline Industries, LPK243244加热呼吸管Guangdong Eda Technology Co., Ltd.K241268Thermalite 加热 CPAP 管道（CTUBH06H15DS-2, CTUBH15-DS）Exceleron MedicalK234032Hudson RCI Dri-Tech 呼吸回路；HUD99035/Dri-Tech 成人回路；HUD99035KIT/Dri-Tech 成人回路套件；HUD99098KIT/单肢成人Dri-Tech 套件；HUD99098KITF/单肢成人Dri-Tech 过滤器套件；HUD900/Dri-Tech 呼吸机附件；HUD901/Dri-Tech 呼吸机附件延长线Medline Industries, LPK222822VentStar Helix 双加热（N）Plus（MP02650），VentStar Helix 加热（N）Plus（MP02608）Draegerwerk AG & CO Kgaa

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