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FDA 510(k)

单电池组浓缩器，带肩带携带包，背包肩带，A，POC1 USB 蓝牙适配器，POC1 Invacare 移动医疗应用程序配件，用于 iOS 和 Android 设备，Invacare Platinum 移动制氧机带连接功能

K号: K191159 · 2019-08-29

申请人Invacare Corporation
决定日期2019-08-29
产品代码CAW
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

Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corporation. It received FDA 510(k) clearance on 2019-08-29 under 510(k) number K191159. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity?

Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity is a medical device that received FDA 510(k) clearance on 2019-08-29. The listed applicant is Invacare Corporation. The 510(k) number is K191159.

When did Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity receive FDA 510(k) clearance?

Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity received FDA 510(k) clearance on 2019-08-29, under 510(k) number K191159.

Who is the listed applicant for Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity?

The FDA 510(k) record lists Invacare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity?

The FDA product code for Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity is CAW.

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

列明Invacare Corporation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。

K203210Invacare Platinum 5NXG 氧气浓缩器K202379Invacare AVIVA Storm RX 动力轮椅K200890Invacare Perfecto2V 氧气浓缩器K192216Invacare AVIVA FX 动力轮椅，型号：IFX-20MPK182946Invacare TDX SP2-HD 配有船长座椅K181090Invacare® Solara® 3G 和 Solara® 3G Spree 手动轮椅

查看所有 14 个设备 →

相关器械（代码：CAW）

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。

K254289便携式制氧机（OX-1A-E，OX-1B）Oxytek Medical Technology Co., Ltd.K260171便携式氧气浓缩器（PO1 5B，PO1 6B）BMC Medical Co., Ltd.K252399便携式制氧机Honsun (Nantong) Co., Ltd.K252965氧气浓缩器 (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd.K252407OxyGo便携式氧气浓缩器（1400-7000）Mv Life, LLCK253549DeVilbiss 5 升制氧机（555）Devilbiss Healthcare, LLC

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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