|
Device | HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories |
Generic Name | Automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant | HeartSine Technologies, Ltd. 207 Airport Road West Belfast, Northern Ireland BT3 9 |
PMA Number | P160008 |
Supplement Number | S002 |
Date Received | 10/02/2018 |
Decision Date | 10/22/2018 |
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 Use of an alternate PCBA functional tester at the component supplier sites. |