Medical Device Manufacturer · NZ , Auckland, New Zealand

Fisher &Paykel Healthcare , Ltd. - FDA 510(k) Cleared Devices

70 submissions · 70 cleared · Since 1988
70
Total
70
Cleared
0
Denied
64 devices
26-50 of 64
Cleared Mar 05, 2015
MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb...
K143646 · BTT
Anesthesiology · 73d
Cleared Mar 25, 2014
HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT
K132017 · BTT
Anesthesiology · 267d
Cleared Dec 04, 2013
MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E...
K131957 · BTT
Anesthesiology · 160d
Cleared Oct 24, 2013
AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
K131895 · BTT
Anesthesiology · 121d
Cleared Jan 03, 2013
AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
K121975 · BTT
Anesthesiology · 182d
Cleared Dec 06, 2012
ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
K122432 · BZE
Anesthesiology · 118d
Cleared Apr 16, 2012
DUAL HEATED INFANT VREATHING CIROUITS
K103767 · BZE
Anesthesiology · 480d
Cleared Mar 30, 2012
RESPIRATORY HUMIDIFER
K110019 · BTT
Anesthesiology · 452d
Cleared Aug 19, 2011
INFOSEND GSM
K110316 · BZD
Anesthesiology · 197d
Cleared Mar 24, 2011
ZEST PETITE NASAL MASK
K103786 · BZD
Anesthesiology · 87d
Cleared Oct 08, 2010
FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM
K100011 · BZD
Anesthesiology · 277d
Cleared May 28, 2010
RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880,...
K100554 · BTT
Anesthesiology · 91d
Cleared Apr 27, 2010
F&P ICON SERIES CPAP
K094040 · BZD
Anesthesiology · 118d
Cleared Jan 27, 2010
AIRVO SERIES HUMIDIFIERS
K092846 · BTT
Anesthesiology · 134d
Cleared Mar 16, 2009
ZEST NASAL MASK
K083832 · BZD
Anesthesiology · 83d
Cleared Mar 04, 2009
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
K083122 · CBK
Anesthesiology · 133d
Cleared Sep 12, 2008
FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK
K080209 · BZD
Anesthesiology · 228d
Cleared Sep 12, 2008
SLEEPSTYLE 200 AUTO SERIES HC254
K081029 · BZD
Anesthesiology · 154d
Cleared Mar 31, 2008
RESPIRATORY HUMIDIFIER, MODEL MR850
K073706 · BTT
Anesthesiology · 91d
Cleared Dec 22, 2006
OPUS HC482 DIRECT NASAL MASK
K063036 · BZD
Anesthesiology · 80d
Cleared Aug 29, 2006
FLEXIFIT HC432 FULL FACE MASK
K061236 · BZD
Anesthesiology · 118d
Cleared Apr 06, 2006
ACUTE CARE FACE MASK, MODEL RT040
K060044 · MNT
Anesthesiology · 90d
Cleared May 25, 2005
CPAP HUMIDIFIER, MODEL HC238JHU
K050904 · BZD
Anesthesiology · 44d
Cleared Jan 12, 2005
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
K034026 · BZE
Anesthesiology · 380d
Cleared Aug 31, 2004
HC604 CPAP HUMIDIFIER
K041900 · BZD
Anesthesiology · 48d
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