PMA P180028S001
- Device
- HeartStart FRx Defibrillator (861304)
- Applicant
- Philips Medical Systems
- PMA number
- P180028
- Supplement
- S001
- Product code
- MKJ
- Decision date
- 2020-07-16
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Implementation of a semi-automated tool used during speaker assembly.
Current openFDA PMA Record#
- Device
- HeartStart FRx Defibrillator (861304)
- Applicant
- Philips Medical Systems
- PMA number
- P180028
- Supplement
- S001
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-07-16
- Decision code
- OK30
- Date received
- 2020-06-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a semi-automated tool used during speaker assembly.