Medical device licence · 77244 · Class 2
QUARK CPET
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
- 77244
- 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
- 44
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
- 3 LITRE CALIBRATION SYRINGE
- ADULT ARTICULATED FINGER CLIP SENSOR
- AMIS24 ADAPTIVE MIXING CHAMBER
- ANT HR MODULE GARMIN
- ANTIBACTERIAL FILTERS
- CANOPY BUBBLEHOOD
- CANOPY POWER SUPPLY
- CARDIAC OUTPUT PLUG ASSEMBLY
- CPET OPTOELECTRONIC READER W/O PERMAPURE
- EAR CLIP SENSOR
- FLOWMETER, TURBINE
- FLOWSAFE FILTER ADAPTER
- K5 CASE KIT
- K5 READER - MASK FITTING W/ OR
- K5 TURBINE W/CASE
- KIT FOR TEST WITH ENRICHED MIXTURES
- KIT, HIGH/LOW FIO2 FOR QUARK CPET
- MASK ADAPTER (6450 SERIES V2 MASK)
- MIXING CHAMBER 2015
- MIXING CHAMBER 2015 UPGRADE KIT (REQUIRES OMNIA)
- OMNIA
- OMNIA AUX DEVICES
- OMNIA REVIEW STATION
- OMNIA SOFTWARE
- OMNIA, SPIROMETRY MODULE
- OXIMETER XPOD, CPET/PFT
- PAPER MOUTHPIECES
- PEDIATRIC FINGER CLIP SENSOR
- PFT INPUT/OUTPUT HR TTL CABLE
- QPFT/CPET, REE MODULE
- QUARK CPET
- QUARK CPET METABOLIC CART O2 GFC
- REFLECTANCE SENSOR
- T/RH PROBE PFT2007
- T5 MIXING CHAMBER OUTPUT FITTING
- TURBINE, T5
- TWO-WAY NON-REBREATHING VALVE TSHAPE SERIES 2700
- USB HEART RATE RECEIVER STICK
- V2 MASK FOR RMR FLOWMETER
- V2 MASK FOR TURBINE 2000
- V2 PEDIATRIC FACE MASK RMR FLOWMETER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.