Medical device licence · 84277 · Class 3
MAC 3500 RESTING ECG SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 26, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84277
- 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 26, 2010
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MAC3500 ACS SOFTWARE PACKAGE
- MAC3500 COLOR NON ENG PACKAGE
- MAC3500 COLOR PACKAGE
- MAC3500 CRITICAL VALUE SOFTWARE PACKAGE
- MAC3500 CT DATA GUARD PACKAGE
- MAC3500 ELECTROCARDIOGRAM SYSTEM UPGRADE KIT
- MAC3500 ELECTROCARDIOGRAPH SYSTEM
- MAC3500 MONO NON ENG PACKAGE
- MAC3500 MONO PACKAGE
- MAC3500 UPG ACS PACKAGE
- MAC3500 UPGRDE CRITICAL VALUES PACKAGE
- MAC35UPG CURRENT SOFTWARE PACKAGE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.