Medical Device Manufacturer · NZ , Auckland

Fisher and Paykel Healthcare Limited

3 submissions · 3 cleared · Since 2017
3
Total
3
Cleared
0
Denied

Fisher and Paykel Healthcare Limited — FDA 510(k) Submissions

Fisher and Paykel Healthcare Limited has submitted 3 FDA 510(k) premarket notifications since 2017, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Ventilator, Continuous, Minimal Ventilatory Support, Facility Use, Ventilator, Continuous, Facility Use, Ventilator, Non-continuous (respirator) . Use the specialty filter in the sidebar to narrow results.

3 devices
1–3 of 3
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)
K233829 · BZD Ventilator,... · Anesthesiology
Aug 2024 266d
F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
K173060 · CBK Ventilator, Continuous,... · Anesthesiology
Jan 2018 119d
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 Small
K170367 · MNT Ventilator, Continuous,... · Anesthesiology
Aug 2017 199d
Filters
All3 Anesthesiology 3