Medical Device Manufacturer · NZ , Auckland

Fisher & Paykel Healthcare Limited - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2012

Recent clearances: F&P Nova Nasal Mask, Airvo Nebulizer Adapter, F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fisher & Paykel Healthcare Limited Anesthesiology ✕

8 devices

1-8 of 8

Cleared Jun 18, 2025

F&P Nova Nasal Mask

Anesthesiology · 210d

Cleared Dec 10, 2021

Airvo Nebulizer Adapter

Anesthesiology · 204d

Cleared Mar 09, 2020

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve...

Anesthesiology · 265d

Cleared Apr 05, 2019

OJR215 Pressure Relief Manifold

Anesthesiology · 480d

Cleared Sep 20, 2016

F&P Eson 2 Nasal Mask

Anesthesiology · 288d

Cleared Jun 05, 2013

F&P SIMPLUS FULL FACE MASK

Anesthesiology · 114d

Cleared Oct 02, 2012

ESON NASAL MASK

Anesthesiology · 124d

Cleared Feb 23, 2012

PILAIRO NASAL PILLOWS MASK

Anesthesiology · 51d