Medical device licence · 9455 · Class 3
HEARTSTREAM FR2 SEMI-AUTOMATIC DEFIBRILLATOR
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed August 6, 1999; ended December 6, 2024. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 9455
- Licence holder
- Philips Medical SystemsAndover, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 6, 1999
- Ended
- December 6, 2024
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FORERUNNER SEMI-AUTOMATIC DEFIBRILLATOR - MAIN UNIT
- HEARTSTART FR2+ SEMI-AUTOMATIC DEFIBRILLATOR - BATTERIES
- HEARTSTART FR2+ SEMI-AUTOMATIC DEFIBRILLATOR - CHARGER
- HEARTSTART FR2+ SEMI-AUTOMATIC DEFIBRILLATOR - CHARGER FOR TRAINING
- HEARTSTART FR2+ SEMI-AUTOMATIC DEFIBRILLATOR - DATA CARD TRAY
- HEARTSTART FR2+ SEMI-AUTOMATIC DEFIBRILLATOR - ECG ASSESSMENT MODULE
- HEARTSTART FR2+ SEMI-AUTOMATIC DEFIBRILLATOR - MAIN UNIT
- HEARTSTART FR2+ SEMI-AUTOMATIC DEFIBRILLATOR - PEDIATRIC PADS
- HEARTSTART FR2+ SEMI-AUTOMATIC DEFIBRILLATOR - PRIMARY BATTERY PACK
- HEARTSTART FR2+ SEMI-AUTOMATIC DEFIBRILLATOR - TRAINING BATTERY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.