PMA P160022S036
- Device
- ZOLL Zenix® Monitor/Defibrillator
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S036
- Product code
- MKJ
- Decision date
- 2025-09-29
- Classification
- Cardiovascular
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- approval for the Zenix Monitor/Defibrillator and related accessories
Current openFDA PMA Record#
- Device
- ZOLL Zenix® Monitor/Defibrillator
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S036
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2025-09-29
- Decision code
- APPR
- Date received
- 2024-04-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the Zenix Monitor/Defibrillator and related accessories