PMA P160033S001
- Device
- Powerheart G5 AED
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160033
- Supplement
- S001
- Product code
- MKJ
- Decision date
- 2018-12-20
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Approval for a cybersecurity software update to prevent corruption or modification of the Powerheart G5 AED software executables.
Current openFDA PMA Record#
- Device
- Powerheart G5 AED
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160033
- Supplement
- S001
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2018-12-20
- Decision code
- APPR
- Date received
- 2018-12-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a cybersecurity software update to prevent corruption or modification of the Powerheart G5 AED software executables.