PMA P180028S002
- Device
- HeartStart FRx Defibrillator
- Applicant
- Philips Medical Systems
- PMA number
- P180028
- Supplement
- S002
- Product code
- MKJ
- Decision date
- 2020-08-03
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Changes to the inspection procedure for components and sub-assemblies used to build the HeartStart family of defibrillators.
Current openFDA PMA Record#
- Device
- HeartStart FRx Defibrillator
- Applicant
- Philips Medical Systems
- PMA number
- P180028
- Supplement
- S002
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-08-03
- Decision code
- OK30
- Date received
- 2020-07-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the inspection procedure for components and sub-assemblies used to build the HeartStart family of defibrillators.