PMA P160026S027
- Device
- LIFEPAK 15 Monitor/Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S027
- Product code
- MKJ
- Decision date
- 2021-06-23
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Implement the use of a new tool to verify the connection of electronic assemblies.
Current openFDA PMA Record#
- Device
- LIFEPAK 15 Monitor/Defibrillator
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S027
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2021-06-23
- Decision code
- OK30
- Date received
- 2021-06-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement the use of a new tool to verify the connection of electronic assemblies.