|
Device | LIFEPAK® CR2 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 | P170018 |
Supplement Number | S002 |
Date Received | 01/11/2019 |
Decision Date | 02/19/2019 |
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 software updates related to device readiness and cellular AED event transmissions. |