|
Device | Powerheart G5 Pediatric Electrodes |
Generic Name | Automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant | ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824 |
PMA Number | P160033 |
Supplement Number | S006 |
Date Received | 04/22/2021 |
Decision Date | 10/07/2021 |
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 a new supplier for the pediatric electrode for the Powerheart G5 Automated External Defibrillator. |