PMA P160026S009
- Device
- LIFEPAK Automated External Defibrillators (AEDs)
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S009
- Product code
- MKJ
- Decision date
- 2019-07-10
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Approval for hardware changes to the power PCBA component and the battery power cable assembly component.
Current openFDA PMA Record#
- Device
- LIFEPAK Automated External Defibrillators (AEDs)
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S009
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2019-07-10
- Decision code
- APPR
- Date received
- 2019-04-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for hardware changes to the power PCBA component and the battery power cable assembly component.