PMA P160033S006
- Device
- Powerheart G5 Pediatric Electrodes
- Applicant
- ZOLL Medical Corporation
- Product code
- MKJ
- Decision date
- 2021-10-07
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Approval for a new supplier for the pediatric electrode for the Powerheart G5 Automated External Defibrillator.
Current openFDA PMA Record#
- Device
- Powerheart G5 Pediatric Electrodes
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160033
- Supplement
- S006
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2021-10-07
- Decision code
- APPR
- Date received
- 2021-04-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new supplier for the pediatric electrode for the Powerheart G5 Automated External Defibrillator.