FDA 510(k) Applications Submitted by REENA DAKEN

FDA 510(k) Number Submission Date Device Name Applicant
K200089 01/15/2020 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/Med Fisher & Paykel Healthcare Ltd.
K220703 03/10/2022 F&P 950 Respiratory Humidifier Fisher & Paykel Healthcare
K211096 04/13/2021 Optiflow Oxygen Kit Fisher &Paykel Healthcare Ltd.
K061236 05/03/2006 FLEXIFIT HC432 FULL FACE MASK FISHER & PAYKEL HEALTHCARE, LTD.
K221338 05/09/2022 F&P Airvo 3 Fisher & Paykel Healthcare
K221436 05/17/2022 F&P 950 Accessory Breathing Circuit Kits Fisher & Paykel Healthcare Ltd
K211560 05/20/2021 Airvo Nebulizer Adapter Fisher & Paykel Healthcare Limited
K251611 05/27/2025 Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOP Fisher & Paykel Healthcare Ltd
K201723 06/23/2020 F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling Fisher & Paykel Healthcare Ltd.
K212031 06/29/2021 F&P 850 AirSpiral Adult NIV and NHF Circuit Kit Fisher & Paykel Healthcare Ltd
K231956 07/03/2023 F&P Optiflow+ Duet Nasal Cannula Fisher & Paykel Healthcare Ltd
K191818 07/05/2019 F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) Fisher & Paykel Healthcare Ltd
K222197 07/22/2022 F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range Fisher & Paykel Healthcare Ltd
K222292 07/29/2022 F&P myAirvo 3 Fisher & Paykel Healthcare
K212371 07/30/2021 F&P Evora Full Face Mask Fisher & Paykel Healthcare Ltd
K233643 11/13/2023 F&P Airvo 3 NIV (PT311US) Fisher & Paykel Healthcare Ltd
K243583 11/20/2024 F&P Nova Nasal Mask Fisher & Paykel Healthcare Limited
K203449 11/23/2020 F&P Visairo NIV Mask Range Fisher & Paykel Healthcare Ltd
K233821 12/01/2023 F&P Optiflow Oxygen Kit (AA451J) Fisher & Paykel Healthcare Ltd
K233829 12/01/2023 Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Fisher and Paykel Healthcare Limited
K223684 12/08/2022 F&P 820 Humidification System Fisher & Paykel Healthcare Ltd
K223696 12/09/2022 F&P Solo Mask Range Fisher & Paykel Healthcare Ltd
K243917 12/20/2024 F&P Optiflow Air/Oxygen Flow Source Fisher & Paykel Healthcare Ltd
K234053 12/22/2023 F&P Optiflow Flow Diverter Fisher & Paykel Healthcare Ltd
K234058 12/22/2023 F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) Fisher & Paykel Healthcare Ltd


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