PMA P160033S002
- Device
- Powerheart G5 Automated External Defibrillator
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160033
- Supplement
- S002
- Product code
- MKJ
- Decision date
- 2019-07-25
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Approval for updates to the Powerheart AED G5 device.
Current openFDA PMA Record#
- Device
- Powerheart G5 Automated External Defibrillator
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160033
- Supplement
- S002
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2019-07-25
- Decision code
- APPR
- Date received
- 2019-04-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updates to the Powerheart AED G5 device.