PMA P160026S010
- Device
- LIFEPAK 20e Defibrillator/Monitor
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S010
- Product code
- MKJ
- Decision date
- 2019-10-25
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Approval for minor design changes to several Printed Circuit Board Assemblies (PCBA) and a printer assembly component.
Current openFDA PMA Record#
- Device
- LIFEPAK 20e Defibrillator/Monitor
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S010
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2019-10-25
- Decision code
- APPR
- Date received
- 2019-06-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor design changes to several Printed Circuit Board Assemblies (PCBA) and a printer assembly component.