| Device Classification Name |
automated external defibrillators (non-wearable) |
|||
|---|---|---|---|---|
| 510(k) Number | K131494 | |||
| Device Name | HEART SYNC | |||
| Applicant |
|
|||
| Applicant Contact | daniel kamm | |||
| Correspondent |
|
|||
| Correspodent Contact | daniel kamm | |||
| Regulation Number | 870.5310 | |||
| Classification Product Code |
|
|||
| Date Received | 05/23/2013 | |||
| Decision Date | 09/16/2013 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Cardiovascular |
|||
| 510k Review Panel |
Cardiovascular |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |