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FDA 510(k)

睡眠呼吸暂停呼吸治疗面罩：YF-01 全脸面罩，YF-02 全脸面罩，YF-03 全脸面罩，YN-02 鼻罩，YN-03 鼻罩，YP-01 鼻枕面罩

K号: K203347 · 2021-07-02

申请人Suzhou Yuyue Medical Technology Co., Ltd.
决定日期2021-07-02
产品代码BZD
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

Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Yuyue Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K203347. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask?

Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Suzhou Yuyue Medical Technology Co., Ltd.. The 510(k) number is K203347.

When did Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask receive FDA 510(k) clearance?

Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask received FDA 510(k) clearance on 2021-07-02, under 510(k) number K203347.

Who is the listed applicant for Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask?

The FDA 510(k) record lists Suzhou Yuyue Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask?

The FDA product code for Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask is BZD.

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：BZD）

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。

K261262Altis 全脸面罩Respironics, Inc.K253044RXiBreeze PAP系统（RXiBreeze 20C）Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan 基础版Resmed CorpK251920睡眠呼吸暂停呼吸治疗面罩：JoyMask 20-B 全脸面罩，JoyMask 21-B 全脸面罩Dcstar, Inc.K253166F6S 全脸面罩（F6S）；P6S 鼻枕接口（P6S）BMC Medical Co., Ltd.

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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