Medical device licence · 77249 · Class 2
QUARK PFT
Yes: licensed in Canada
Licence status Issued (active); first licensed June 3, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 77249
- Licence holder
- Cosmed S.R.L.Albano Laziale, RM, Italy
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 3, 2008
- Devices covered
- 88
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 18 ID RMR FLOWMETER, QUARK 2007
- 2 WAY VALVE VO2MAX FLOWMETER ADAPTER
- 2730 SERIES 2W NRBV Y-SHAPE WITH CUSTOM ID TAPERED COMMON
- 28 ID DIGITAL FLOWMETER, QUARK PFT
- 3 LITRE CALIBRATION SYRINGE
- ADAPTER, MASK W AB FILTER
- AMIS24 ADAPTIVE MIXING CHAMBER
- ANT+/BLE HEART RATE MONITOR W/BELT
- ANTI-MICROBIAL FILTER
- ANTIBACTERIAL FILTERS
- CANOPY BUBBLEHOOD
- CANOPY POWER SUPPLY
- CARDIAC OUTPUT PLUG ASSEMBLY
- CPET MODULE
- DIGITAL FLOWMETER ID28
- DOSIMETER MODULE
- DOSIMETER, PLUG
- FLOWMETER, PNT MODULE (RETROFIT)
- FLOWMETER, PNT X9 MODULE
- FLOWMETER, TURBINE (ID28) MODULE
- FLOWMETER, TURBINE (ID28) MODULE (RETROFIT)
- FLOWMETER, TURBINE (ID28) SPIRO MODULE (RETROFIT)
- FLOWSAFE FILTER ADAPTER
- HR PROBE
- K5 READER - MASK FITTING W/ OR
- KIT FOR TEST WITH ENRICHED MIXTURES
- KIT, HIGH/LOW FIO2 FOR QUARK CPET
- MASK ADAPTER (6450 SERIES V2 MASK)
- MEMBRANE, FOR SMART VALVE
- MIXING CHAMBER 2015
- MIXING CHAMBER 2015 UPGRADE KIT (REQUIRES OMNIA)
- MOUTHPIECE ADAPTER SPIROMETRY
- NASAL PROBE
- NEBULIZER (DEVILBISS 646)
- NEBULIZERS MOUTHPIECE
- OMNIA
- OMNIA AUX DEVICES
- OMNIA PACKAGE
- OMNIA REVIEW STATION
- OMNIA, SPIROMETRY MODULE
- OMNIA, WALKING TESTS/TITRATION MODULE
- OXYGEN SENSOR OOM109-LF2
- PAPER MOUTHPIECES
- PERMAPURE L2M W/ ADAPTER AND LABEL
- PFT INPUT/OUTPUT HR TTL CABLE
- PFT POLAR HR PROBE
- PNT X9 MODULE
- Q-I2M, FOT MODULE
- Q-I2M, FOT MODULE - RETROFIT
- QPFET MODULE, RESP. MECHANICS+PNT (RETROFIT)
- QPFT MODULE, CPET O2 GFC
- QPFT MODULE, DLCO
- QPFT MODULE, LUNG VOLUMES
- QPFT MODULE, LUNG VOLUMES O2 GFC
- QPFT MODULE, LUNG VOLUMES O2 PARAMAGNET
- QPFT MODULE, Q-BOX
- QPFT MODULE, Q-BOX (BENCH)
- QPFT MODULE, RESPIRATORY
- QPFT/CPFT, RFF MODULE
- QPFT/QSPIRO MODULE, AIRWAY RESISTANCE
- QUARK CPET METABOLIC CART O2 GFC
- QUARK PFT
- RMR DIGITAL FLOWMETER PLUG
- ROCC PFT UNIT
- ROCC PNT
- RUBBER MOUTHPIECES
- SMART VALVE
- SMART VALVE FOR T2000 TURBINE FLOW
- SMART VALVE FOR X9 PNT FLOWMETER (X9 SN> 1000)
- SMART VALVE PNT, Q-BOX
- SMART VALVE TURBINE, Q-BOX
- SMART VALVE, DEMAND VALVE
- T/RH PROBE PFT2007
- T5 MIXING CHAMBER OUTPUT FITTING
- TRASMETTITORE WEARLINK 31 HR POLAR
- TURBINE QSPIRO
- TURBINE T6
- TURBINE, T3
- TURBINE, T5
- TWO-WAY NON-REBREATHING VALVE TSHAPE SERIES 2700
- V2 FACE MASK ADULT
- V2 FACE MASK ONLY PETITE
- V2 FACE MASK RMR FLOMETER
- V2 MASK FOR TURBINE 2000
- V2 MASK FOR VO2MAX FLOWMETER
- V2 MASK W\ INSPIRATORY VALVE
- VO2MAX FLOWMETER FACE MASK PLUG
- X9 PNT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.