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 |
| 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 |
| 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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