Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K120536 |
Device Name |
HEART SYNC PEDIATRIC PHYSIO AED PAD |
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 | 02/22/2012 |
Decision Date | 08/06/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|