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FDA 510(k)

單電池組濃縮器，配備可攜帶背包和肩帶，A型，POC1 USB 藍牙擴充棒，POC1 Invacare 移動醫療應用附加設備，適用於 iOS 和 Android 裝置，Invacare 銀河系移動氧濃縮器，具連接功能

K 號：K191159 · 2019-08-29

申請人Invacare Corporation
決定日期2019-08-29
產品代碼CAW
諮詢委員會AN
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Invacare Corporation 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K203210Invacare 銀河5NXG 氧氣濃縮機K202379Invacare AVIVA 風暴 RX 電動輪椅K200890Invacare 完美2V 氧氣濃縮機K192216Invacare AVIVA FX 電動輪椅，型號：IFX-20MPK182946Invacare TDX SP2-HD 配有船長座椅K181090Invacare® Solara® 3G 及 Solara® 3G Spree 手動輪椅手冊

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相關器械（代碼：CAW）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254289攜帶式氧氣濃縮器（OX-1A-E，OX-1B）Oxytek Medical Technology Co., Ltd.K260171攜帶式氧氣濃縮器（PO1 5B，PO1 6B）BMC Medical Co., Ltd.K252399可攜式氧氣濃縮器Honsun (Nantong) Co., Ltd.K252965氧濃度濃縮器（OX-5A、OX-5C）Oxytek Medical Technology Co., Ltd.K252407氧氣Go可攜式氧氣濃縮器（1400-7000）Mv Life, LLCK253549DeVilbiss 5公升氧濃度濃縮機（555）Devilbiss Healthcare, LLC

官方來源

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