|
Device | HeartStart FRx Defibrillator (861304) |
Generic Name | Automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant | Philips Medical Systems 22100 Bothell Everett Hwy Bothell, WA 98021 |
PMA Number | P180028 |
Supplement Number | S014 |
Date Received | 01/23/2024 |
Decision Date | 02/21/2024 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for a battery manufacturing site located at Panasonic Energy Mexico, S.A. de C.V., Escobedo N.L., Mexico |