Medical device licence · 84026 · Class 3
MAC 5500 RESTING ECG SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 1, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84026
- Licence holder
- Ge Medical Systems Information Technologies Inc.Milwaukee, WI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 1, 2010
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MAC 5500 HD RESTING ECG SYSTEM - MAIN UNIT
- MAC 5500 HD RESTING ECG SYSTEM - UPGRADE KIT
- MAC5500 HD ACI-TIPI SOFTWARE PACKAGE
- MAC5500 HD ACS SOFTWARE PACKAGE
- MAC5500 HD COLOR PACKAGE
- MAC5500 HD COLOR W/STRESS PACKAGE
- MAC5500 HD CRITICAL VALUES SOFTWARE PACKAGE
- MAC5500 HD CT DATA GUARD PACKAGE
- MAC5500 HD HI-RES SOFTWARE PACKAGE
- MAC5500 HD PHI-RES SOFTWARE PACKAGE
- MAC5500 HD REMOTE QUERY SOFTWARE PACKAGE
- MAC5500 HD STRESS AHA PACKAGE
- MAC5500 HD STRESS IEC PACKAGE
- MAC55UPGRD ACS PACKAGE
- MAC55UPGRD CRITICAL VALUES PACKAGE
- MAC55UPGRD CURRENT SOFTWARE PACKAGE
- MAC55UPGRD HD SOFTWARE W/COLOR PACKAGE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.