Medical device licence · 112739 · Class 2
PCA 12-LEAD ECG
Yes: licensed in Canada
Licence status Issued (active); first licensed February 19, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 112739
- Licence holder
- Qt Medical, Inc.Diamond Bar, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- February 19, 2025
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PCA 300 12-LEAD ECG
- PCA 500 12-LEAD ECG
- PCA-A300 ECG CABLE CONVERTER
- PCA-A400 EXTENSION CABLE
- PCA-C100 BL PATIENT CABLE AHA
- PCA-C100 BS PATIENT CABLE AHA
- PCA-C101 BL PATIENT CABLE IEC
- PCA-C101 BS PATIENT CABLE IEC
- QT ECG APP - ANDROID
- QT ECG APP- IOS
- QT ECG DISPOSABLE ELECTRODE STRIP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.