Medical device licence · 73329 · Class 2
PULMONARY FUNCTION UNIT - VIRAL/BACTERIAL FILTER
Yes: licensed in Canada
Licence status Issued (active); first licensed February 15, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 73329
- Licence holder
- A-M Systems, LlcSequim, WA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- February 15, 2007
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HEAT & MOISTURE FILTER EXCHANGE
- HYDROMAX, HME FILTER
- PULMONARY FUNCTION FILTER - VBMAX
- VBMAX 33 DISPOSABLE FILTER
- VBMAX30 FILTER, DISPOSABLE BACTERIAL/VIRAL FILTER
- VBMAX34E, PF TESTING FILTER
- VIRAL AND BACTERIAL FILTER
- VIROMAX - BACTERIAL AND VIRAL FILTER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.