PMA P180028S012
- Device
- HeartStart FRx Defibrillator
- Applicant
- Philips Medical Systems
- PMA number
- P180028
- Supplement
- S012
- Product code
- MKJ
- Decision date
- 2022-03-20
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Alternate supplier for the high voltage capacitor used for the HS1 and FRx devices.
Current openFDA PMA Record#
- Device
- HeartStart FRx Defibrillator
- Applicant
- Philips Medical Systems
- PMA number
- P180028
- Supplement
- S012
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2022-03-20
- Decision code
- OK30
- Date received
- 2022-02-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for the high voltage capacitor used for the HS1 and FRx devices.