PMA P160026S074
- Device
- LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S074
- Product code
- MKJ
- Decision date
- 2026-09-24
- Classification
- Cardiovascular
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- implementation of an automated inspection process
Current openFDA PMA Record#
- Device
- LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S074
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2026-09-24
- Decision code
- OK30
- Date received
- 2026-09-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of an automated inspection process