|
Device | AED 3 defibrillator |
Generic Name | automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant | ZOLL MEDICAL CORPORATION 269 & 271 mill road chelmsford, MA 01824 |
PMA Number | P160015 |
Supplement Number | S001 |
Date Received | 08/18/2017 |
Decision Date | 02/28/2020 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 180 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the AED 3 Defibrillator. |
Post-Approval Study | Show Report Schedule and Study Progress |