Medical device licence · 81457 · Class 2
ELECTRO CARDIOGRAPH
Yes: licensed in Canada
Licence status Issued (active); first licensed December 11, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 81457
- Licence holder
- Philips Medizin Systeme Boblingen GmbhBoblingen, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 11, 2009
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 12-LEAD CHEST LEAD SET (AAMI/IEC), LONG
- 12-LEAD CHEST LEAD SET (AAMI/IEC), STANDARD LENGTH
- 12-LEAD COMPLETE LEAD SET (AAMI), LONG
- 12-LEAD COMPLETE LEAD SET (AAMI), STANDARD LENGTH
- 12-LEAD COMPLETE LEAD SET (IEC), LONG
- 12-LEAD COMPLETE LEAD SET (IEC), STANDARD LENGTH
- 12-LEAD LIMB LEAD SET (AAMI/IEC), LONG
- 12-LEAD LIMB LEAD SET (AAMI/IEC), STANDARD LENGTH
- ALLIGATOR CLIPS, AAMI
- ALLIGATOR CLIPS, IEC
- CLEAR TAB/SNAP ADAPTER
- PAGEWRITER TC30 - ELECTRO CARDIOGRAPH
- PAGEWRITER TC30 - PATIENT INTERFACE MODULE (PIM)
- PW EXCHANGE PIM III 12L AAMI
- USB PATIENT DATA CABLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.