|
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 | S011 |
Date Received | 10/18/2021 |
Decision Date | 11/15/2021 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Updates to the test limits of the Final Acceptance Test. |