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Fisher & Paykel Healthcare Limited

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K262268 Optiflow Oxygen Kit (AA484J)BTT2026-08-27 View
510(k) K243583 F&P Nova Nasal MaskBZD2025-06-18 View
510(k) K233829 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); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA)BZD2024-08-23 View
510(k) K211560 Airvo Nebulizer AdapterCAF2021-12-10 View
510(k) K191624 F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionMNT2020-03-09 View
510(k) K173770 OJR215 Pressure Relief ManifoldCBP2019-04-05 View
510(k) K173060 F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow VersionCBK2018-01-25 View
510(k) K170367 Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra SmallMNT2017-08-24 View
510(k) K153505 F&P Eson 2 Nasal MaskBZD2016-09-20 View
510(k) K130328 F&P SIMPLUS FULL FACE MASKBZD2013-06-05 View
510(k) K121597 ESON NASAL MASKBZD2012-10-02 View
510(k) K120027 PILAIRO NASAL PILLOWS MASKBZD2012-02-23 View
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