Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K131550 |
Device Name |
HEART SYNC |
Applicant |
HEART SYNC INC. |
8870 RAVELLO CT |
NAPLES,
FL
34114
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
HEART SYNC INC. |
8870 RAVELLO CT |
NAPLES,
FL
34114
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 05/29/2013 |
Decision Date | 12/06/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|