|
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 | S014 |
Date Received | 07/27/2022 |
Decision Date | 09/27/2022 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new packaging design, which will include new corrugated cardboard packaging components to replace the current packaging components. |