Medical device licence · 85024 · Class 2
MULTI-COMPATIBLE SP02 SENSORS
Yes: licensed in Canada
Licence status Issued (active); first licensed January 31, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85024
- Licence holder
- Advantage Medical Electronics, LlcCoral Springs, FL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- January 31, 2011
- Devices covered
- 19
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NELLCOR COMPATIBLE MEDIUM SOFTTIP SP02 SENSOR
- NK COMPATABLE MEDIUM SOFTTIP SPO2 SENSOR
- PR-A120 SERIES - SMALL REUSABLE SPO2 FINGER SENSORS
- PR-A220 SERIES - REUSABLE EAR SPO2 SENSORS
- PR-A320 SERIES - REUSABLE OMNI-SITE SPO2 SENSORS
- PR-A520 SERIES - REUSABLE LARGE FINGER SPO2 SENSORS
- PR-A800 SERIES - REUSABLE SMALL SOFT TIP SPO2 SENSORS
- PR-A850 SERIES - REUSABLE MEDIUM SOFT TIP SPO2 SENSORS
- PR-A900 SERIES - REUSABLE LARGE SOFT TIP SPO2 SENSORS
- PR-E600 SERIES - DISPOSABLE ADULT MICRO-FOAM SPO2 SENSORS
- PR-E610 SERIES - DISPOSABLE PEDI MICRO-FOAM SPO2 SENSORS
- PR-E620 SERIES - DISPOSABLE INFANT MICRO-FOAM SPO2 SENSORS
- PR-P600 SERIES - DISPOSABLE ADULT MEDAPLAST SPO2 SENSORS
- PR-P610 SERIES - DISPOSABLE PEDI MEDAPLAST SPO2 SENSORS
- PR-P620 SERIES - DISPOSABLE INFANT MEDAPLAST SPO2 SENSORS
- PR-P630 SERIES - DISPOSABLE NEO NAT MEDAPLAST SPO2 SENSORS
- PR-T600 SERIES - DISPOSABLE ADULT TRANS-PORE SPO2 SENSORS
- PR-T610 SERIES - DISPOSABLE PEDI TRANS-PORE SPO2 SENSORS
- SMALL SOFT TIP, DATEX (LEGACY) COMP.
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.