- Device
- QUIK-COMBO® Therapy Cable (a necessary AED accessory of the LIFEPAK® 15 Monitor/Defibrillator)
- Applicant
- Physio-Control, Inc.
- PMA number
- P160026
- Supplement
- S029
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2021-09-15
- Decision code
- OK30
- Date received
- 2021-08-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the final electrical inspection test step and implementation of a new electrical test fixture.