FDA 510(k) Applications Submitted by FISHER & PAYKEL HEALTHCARE, LTD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110019 |
01/03/2011 |
RESPIRATORY HUMIDIFER |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K034026 |
12/29/2003 |
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K073706 |
12/31/2007 |
RESPIRATORY HUMIDIFIER, MODEL MR850 |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K060044 |
01/06/2006 |
ACUTE CARE FACE MASK, MODEL RT040 |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K020332 |
01/31/2002 |
RESPIRATORY HUMIDIFIER, MODEL MR850 |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K131895 |
06/25/2013 |
AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K121975 |
07/05/2012 |
AIRVO HUMIDIFIER MYAIRO HUMIDIFIER |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K002414 |
08/07/2000 |
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K033710 |
11/26/2003 |
MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K953205 |
05/30/1995 |
CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION) |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K982636 |
07/29/1998 |
PATIENT WARMER- MODEL PW810 |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K983112 |
09/04/1998 |
RESPIRATORY HUMIDIFIER, MODEL # MR850 |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K002839 |
09/12/2000 |
END EXPIRATORY FILTER, MODEL RT020 |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K003973 |
12/22/2000 |
RESPIRATORY HUMIDIFIER, MODEL HC150 |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K003894 |
12/18/2000 |
ORACLE ORAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K131957 |
06/27/2013 |
MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K132017 |
07/01/2013 |
HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K100554 |
02/26/2010 |
RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441 |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K110316 |
02/03/2011 |
INFOSEND GSM |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K040506 |
02/27/2004 |
FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K050904 |
04/11/2005 |
CPAP HUMIDIFIER, MODEL HC238JHU |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K081029 |
04/11/2008 |
SLEEPSTYLE 200 AUTO SERIES HC254 |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K040941 |
04/12/2004 |
CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K041900 |
07/14/2004 |
HC604 CPAP HUMIDIFIER |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K092846 |
09/15/2009 |
AIRVO SERIES HUMIDIFIERS |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K033087 |
09/29/2003 |
ORACLE ORAL MASK, MODEL HC451A |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K094040 |
12/30/2009 |
F&P ICON SERIES CPAP |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K063036 |
10/03/2006 |
OPUS HC482 DIRECT NASAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K023559 |
10/23/2002 |
FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K061236 |
05/03/2006 |
FLEXIFIT HC432 FULL FACE MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K050927 |
04/13/2005 |
RT019 INSPIRATORY/EXPIRATORY FILTER |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K100011 |
01/04/2010 |
FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K040366 |
02/13/2004 |
PRESSURE MANIFOLD, MODEL BC 110 |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K022609 |
08/06/2002 |
SURGICAL PATIENT WARMER, MODEL PW820 JHU |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K122432 |
08/10/2012 |
ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K023670 |
10/31/2002 |
SINGLE USE ORAL MASK, MODEL HC455A |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K083122 |
10/22/2008 |
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041 |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K080209 |
01/28/2008 |
FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K083832 |
12/23/2008 |
ZEST NASAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K103786 |
12/27/2010 |
ZEST PETITE NASAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
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