PMA P160026S006
- Device
- LIFEPAK® 20e defibrillator/monitor
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S006
- Product code
- MKJ
- Decision date
- 2019-05-09
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Manufacturing process change that impacts the pulse oximetry (Sp02) module component of the LIFEPAK 20e defibrillator/monitor.
Current openFDA PMA Record#
- Device
- LIFEPAK® 20e defibrillator/monitor
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S006
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2019-05-09
- Decision code
- OK30
- Date received
- 2019-04-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process change that impacts the pulse oximetry (Sp02) module component of the LIFEPAK 20e defibrillator/monitor.