|
Device | Powerheart® G5 AED |
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 | S010 |
Date Received | 11/13/2023 |
Decision Date | 12/21/2023 |
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 two components on the printed circuit board assembly (PCBA) that are obsolete and six ancillary changes to the PCBA for ease of manufacturing. |