Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K041067 |
Device Name |
HEARTSINE SAMARITAN PAD |
Applicant |
HEARTSINE TECHNOLOGIES, INC. |
940 CALLE AMANECER, SUITE E |
SAN CLEMENTE,
CA
92673
|
|
Applicant Contact |
WILLIAM J SMIRLES |
Correspondent |
HEARTSINE TECHNOLOGIES, INC. |
940 CALLE AMANECER, SUITE E |
SAN CLEMENTE,
CA
92673
|
|
Correspondent Contact |
WILLIAM J SMIRLES |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 04/23/2004 |
Decision Date | 05/25/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|