PMA P160026S024
- Device
- LIFEPAK 15 Monitor/Defibrillator and LIFEPAK 20e Defibrillator/Monitor
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S024
- Product code
- MKJ
- Decision date
- 2021-03-19
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Replacement of the washing system used during capacitor manufacturing.
Current openFDA PMA Record#
- Device
- LIFEPAK 15 Monitor/Defibrillator and LIFEPAK 20e Defibrillator/Monitor
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S024
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2021-03-19
- Decision code
- OK30
- Date received
- 2021-02-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of the washing system used during capacitor manufacturing.