Medical device licence · 96479 · Class 3
RHYTHMIA MAPPING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 3, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96479
- Licence holder
- Boston Scientific CorporationWatertown, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 3, 2016
- Devices covered
- 23
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MAGNETIC TRACKING SYSTEM - MALE TO MALE TIP - JACKS
- RHYTHMIA MAPPING SYSTEM - BREAKOUT BOX
- RHYTHMIA MAPPING SYSTEM - CABLES
- RHYTHMIA MAPPING SYSTEM - CONDITIONING BOX
- RHYTHMIA MAPPING SYSTEM - CONNECTION BOX
- RHYTHMIA MAPPING SYSTEM - ECG BOX OUT
- RHYTHMIA MAPPING SYSTEM - ECG CABLE
- RHYTHMIA MAPPING SYSTEM - ECG OUT BOX AND CABLE KIT
- RHYTHMIA MAPPING SYSTEM - FIBER OPTIC ADAPTER KIT
- RHYTHMIA MAPPING SYSTEM - FOOT SWITCH
- RHYTHMIA MAPPING SYSTEM - GLOBAL INSTALL BUNDLE
- RHYTHMIA MAPPING SYSTEM - LOCALIZATION GENERATOR
- RHYTHMIA MAPPING SYSTEM - LOCALIZATION UNIT
- RHYTHMIA MAPPING SYSTEM - LOCATION REFERENCE PATCH KIT
- RHYTHMIA MAPPING SYSTEM - MAGNETIC TRACKING SYSTEM
- RHYTHMIA MAPPING SYSTEM - RHYTHMIA REVIEW STATION PC
- RHYTHMIA MAPPING SYSTEM - RHYTHMIA SOFTWARE V1.0
- RHYTHMIA MAPPING SYSTEM - RHYTHMIA WORKSTATION PC
- RHYTHMIA MAPPING SYSTEM - SIGNAL STATION
- RHYTHMIA MAPPING SYSTEM - SIU (SENSOR INTERFACE UNIT)
- RHYTHMIA MAPPING SYSTEM - USB
- RHYTHMIA MAPPING SYSTEM SOFTWARE V1.2
- RHYTHMIA SOFTWARE V1.4
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.