PMA P180028S005
- Device
- HeartStart FRx Defibrillator
- Applicant
- Philips Medical Systems
- Product code
- MKJ
- Decision date
- 2021-04-06
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Approval for a change in speaker component for the HeartStart FRx, OnSite, and Home Defibrillator devices.
Current openFDA PMA Record#
- Device
- HeartStart FRx Defibrillator
- Applicant
- Philips Medical Systems
- PMA number
- P180028
- Supplement
- S005
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2021-04-06
- Decision code
- APPR
- Date received
- 2021-01-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in speaker component for the HeartStart FRx, OnSite, and Home Defibrillator devices.