PMA P180028S006

Device: HeartStart FRx Defibrillator
Applicant: Philips Medical Systems
PMA number: P180028
Supplement: S006
Product code: MKJ
Decision date: 2021-02-12
Generic name: Automated external defibrillators (non-wearable)
Approval order statement: Inspection procedure changes for components and sub-assemblies used in the manufacture of the HeartStart OnSite Defibrillator (Model M5066A), HeartStart Home Defibrillator (Model M5068A) and HeartStart FRx Defibrillator (Model 861304).

Current openFDA PMA Record#

Device: HeartStart FRx Defibrillator
Applicant: Philips Medical Systems
PMA number: P180028
Supplement: S006
Product code: MKJ
Generic name: Automated external defibrillators (non-wearable)
Decision date: 2021-02-12
Decision code: OK30
Date received: 2021-01-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Inspection procedure changes for components and sub-assemblies used in the manufacture of the HeartStart OnSite Defibrillator (Model M5066A), HeartStart Home Defibrillator (Model M5068A) and HeartStart FRx Defibrillator (Model 861304).