|
Device | LIFEPAK® 15 monitor/defibrillator |
Generic Name | Automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant | Physio-Control. Inc. 11811 Willows Road NE Redmond, WA 98052 |
PMA Number | P160026 |
Supplement Number | S042 |
Date Received | 09/27/2023 |
Decision Date | 12/22/2023 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for hardware changes being made to the Printed Circuit Board Assemblies (PCBAs), Cable Assemblies, Keypads, and Energy Storage Capacitor components as well as for changes made due to end-of-life components. |