Fisher & Paykel Healthcare, Ltd.
FDA 510(k) medical device clearances.
Top product codes for Fisher & Paykel Healthcare, Ltd.
Recent clearances by Fisher & Paykel Healthcare, Ltd.
- K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
- K250651 — OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun
- K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full
- K243917 — F&P Optiflow Air/Oxygen Flow Source
- K251611 — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)
- K233643 — F&P Airvo 3 NIV (PT311US)
- K234053 — F&P Optiflow Flow Diverter
- K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)
- K233821 — F&P Optiflow Oxygen Kit (AA451J)
- K231956 — F&P Optiflow+ Duet Nasal Cannula
- K223684 — F&P 820 Humidification System
- K221436 — F&P 950 Accessory Breathing Circuit Kits
- K223696 — F&P Solo Mask Range
- K222197 — F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range
- K212031 — F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
- K212371 — F&P Evora Full Face Mask
- K211096 — Optiflow Oxygen Kit
- K203449 — F&P Visairo NIV Mask Range
- K201723 — F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling
- K200089 — F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model
- K191818 — F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
- K190713 — F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)
- K173193 — F&P SleepStyle
- K161686 — F&P InfoSmart
- K161412 — F&P Brevida Nasal Pillows Mask
- K143646 — MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
- K132017 — HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT
- K133666 — RT016 INSPIRATORY FILTER
- K131957 — MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT
- K131895 — AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
- K121975 — AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
- K122432 — ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
- K103767 — DUAL HEATED INFANT VREATHING CIROUITS
- K110019 — RESPIRATORY HUMIDIFER
- K110316 — INFOSEND GSM
- K103786 — ZEST PETITE NASAL MASK
- K100011 — FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM
- K100554 — RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441
- K094040 — F&P ICON SERIES CPAP
- K092846 — AIRVO SERIES HUMIDIFIERS
- K083832 — ZEST NASAL MASK
- K083122 — HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
- K080209 — FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK
- K081029 — SLEEPSTYLE 200 AUTO SERIES HC254
- K073706 — RESPIRATORY HUMIDIFIER, MODEL MR850
- K063036 — OPUS HC482 DIRECT NASAL MASK
- K061236 — FLEXIFIT HC432 FULL FACE MASK
- K060044 — ACUTE CARE FACE MASK, MODEL RT040
- K050927 — RT019 INSPIRATORY/EXPIRATORY FILTER
- K050904 — CPAP HUMIDIFIER, MODEL HC238JHU
- K034026 — RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
- K041900 — HC604 CPAP HUMIDIFIER
- K040941 — CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)
- K040506 — FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A
- K033710 — MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU
- K040366 — PRESSURE MANIFOLD, MODEL BC 110
- K033087 — ORACLE ORAL MASK, MODEL HC451A
- K020332 — RESPIRATORY HUMIDIFIER, MODEL MR850
- K023559 — FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK
- K023670 — SINGLE USE ORAL MASK, MODEL HC455A
- K022609 — SURGICAL PATIENT WARMER, MODEL PW820 JHU
- K002839 — END EXPIRATORY FILTER, MODEL RT020
- K003894 — ORACLE ORAL MASK
- K003973 — RESPIRATORY HUMIDIFIER, MODEL HC150
- K002414 — PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
- K983112 — RESPIRATORY HUMIDIFIER, MODEL # MR850
- K982636 — PATIENT WARMER- MODEL PW810
- K953205 — CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION)
- K881970 — MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER
- K882438 — CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252
Data sourced from openFDA. This site is unofficial and independent of the FDA.