|
Device | HeartStart FR3 Defibrillator |
Generic Name | Automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant | PHILIPS MEDICAL SYSTEMS, INC. 22100 Bothell-Everett Highway Bothell, WA 98021 |
PMA Number | P160028 |
Supplement Number | S003 |
Date Received | 11/16/2020 |
Decision Date | 12/16/2020 |
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 Updates to the inspection process for various device components and sub-assemblies. |