Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K052465 |
Device Name |
REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 |
Applicant |
HEARTSINE TECHNOLOGIES, INC. |
105 TERRY DR |
NEWTOWN,
PA
18940
|
|
Applicant Contact |
GEORGE BRDLIK |
Correspondent |
HEARTSINE TECHNOLOGIES, INC. |
105 TERRY DR |
NEWTOWN,
PA
18940
|
|
Correspondent Contact |
GEORGE BRDLIK |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 09/08/2005 |
Decision Date | 12/12/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|