FDA 510(k) Applications Submitted by Fisher & Paykel Healthcare Ltd

FDA 510(k) Number Submission Date Device Name Applicant
K143646 12/22/2014 MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit Fisher & Paykel Healthcare Ltd
K173193 10/02/2017 F&P SleepStyle Fisher & Paykel Healthcare Ltd
K221436 05/17/2022 F&P 950 Accessory Breathing Circuit Kits Fisher & Paykel Healthcare Ltd
K212031 06/29/2021 F&P 850 AirSpiral Adult NIV and NHF Circuit Kit 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
K212371 07/30/2021 F&P Evora Full Face Mask Fisher & Paykel Healthcare Ltd
K203449 11/23/2020 F&P Visairo NIV Mask Range Fisher & Paykel Healthcare Ltd
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


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