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FDA 510(k)

F&P Evora鼻枕面罩鼻部A型（小号、中号、大号、宽版），F&P Evora鼻枕面罩鼻部适配包/ SML（小号/中号/大号）A型，F&P Evora鼻枕面罩鼻部睡眠实验室（小号、中号、大号、宽版），F&P Evora鼻枕面罩鼻部适配包 / SML（小号/中号/大号）睡眠实验室型号

K号: K200089 · 2020-06-02

申请人Fisher & Paykel Healthcare, Ltd.
决定日期2020-06-02
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

F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2020-06-02 under 510(k) number K200089. 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 F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model?

F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model is a medical device that received FDA 510(k) clearance on 2020-06-02. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K200089.

When did F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model receive FDA 510(k) clearance?

F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model received FDA 510(k) clearance on 2020-06-02, under 510(k) number K200089.

Who is the listed applicant for F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model?

The FDA 510(k) record lists Fisher & Paykel Healthcare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model?

The FDA product code for F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model is BZD.

相关临床试验

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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

列明Fisher & Paykel Healthcare, Ltd.为申报人的其他记录

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。

K253479Optiflow Switch+ 过滤鼻接口带CO2采样（AA042J）K250651OptiPAP Junior Flexi Tube US (OPTIPAPFUS)；OptiPAP Junior 鼻塞 XXS (OPTIPAPPXXS)；OptiPAP Junior 鼻塞 XS (OPTIPAPPXS)；OptiPAP Junior 鼻塞 S (OPTIPAPPS)；OptiPAP Junior 鼻塞 M (OPTIPAPPM)；OptiPAP Junior 鼻塞 L (OPTIPAPPL)；OptiPAP Junior 鼻塞 XL (OPTIPAPPXL)；OptiPAP Junior 鼻罩 XXS (OPTIPAPMXXS)；OptiPAP Junior 鼻罩 XS (OPTIPAPMXS)；OptiPAP Junior 鼻罩 S (OPTIPAPMS)；OptiPAP Junior 鼻罩 M (OPTIPAPMM)；OptiPAP JunK252173F&P OptiNIV医院通气全脸面罩与单肢电路兼容 - 尺寸A (ONIV117A)；F&P OptiNIV医院通气全脸面罩与单肢电路兼容 - 尺寸B (ONIV117B)；F&P OptiNIV医院通气全脸面罩与单肢电路兼容 - 尺寸C (ONIV117C)；F&P OptiNIV ONIV117-F医院通气全脸面罩带可选呼气过滤器与单肢电路兼容 - 尺寸A (ONIV117A-F)；F&P OptiNIV ONIV117-F医院通气全脸面罩K243917F&P Optiflow空气/氧气流量源K251611Optiflow+ 鼻导管 - 小型（OPT942）；Optiflow+ 鼻导管 - 中型（OPT944）；Optiflow+ 鼻导管 - 大型（OPT946）；Optiflow+ 鼻导管 小型（MYOPT9SMALL）；Optiflow+ 鼻导管 中型（MYOPT9MEDIUM）；Optiflow+ 鼻导管 大型（MYOPT9LARGE）K233643F&P Airvo 3 NIV (PT311US)

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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.

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