|
Device | CPR Stat-Padz Electrode and CPR-D Padz Electrode |
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 | S002 |
Date Received | 08/23/2018 |
Decision Date | 03/27/2019 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for automation of a soldering process. |