FDA 510(k) Applications Submitted by Fisher and Paykel Healthcare Limited

FDA 510(k) Number	Submission Date	Device Name	Applicant
K173060	09/28/2017	F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version	Fisher and Paykel Healthcare Limited
K170367	02/06/2017	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	Fisher and Paykel Healthcare Limited
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