PMA P160026S001
- Device
- LIFEPAK 15 Monitor/Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S001
- Product code
- MKJ
- Decision date
- 2018-08-06
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Approval for modifications to the non-invasive blood pressure (NIBP) module, MiniMedi CO2 module and CO2 Filterline Recognition Safe Guard assembly (FRS) components of the LIFEPAK 15 Monitor/Defibrillator.
Current openFDA PMA Record#
- Device
- LIFEPAK 15 Monitor/Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S001
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2018-08-06
- Decision code
- APPR
- Date received
- 2018-07-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifications to the non-invasive blood pressure (NIBP) module, MiniMedi CO2 module and CO2 Filterline Recognition Safe Guard assembly (FRS) components of the LIFEPAK 15 Monitor/Defibrillator.