|
Device | R Series Device |
Generic Name | Automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant | ZOLL MEDICAL CORPORATION 269 & 271 MILL ROAD CHELMSFORD, MA 01824-4105 |
PMA Number | P160022 |
Supplement Number | S024 |
Date Received | 12/17/2020 |
Decision Date | 01/05/2021 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of a selective soldering machine used during printed circuit board assembly (PCBA) manufacturing. |