|
Device | Physio-Control LIFEPAK® 20e defibrillator/monitor |
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 | S028 |
Date Received | 08/16/2021 |
Decision Date | 11/02/2021 |
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 minor design changes to the System Controller Printed Circuit Board Assembly associated with the LIFEPAK 20e device. |