Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K142709 |
Device Name |
samaritan PAD 450P |
Applicant |
HEARTSINE TECHNOLOGIES, INC. |
121 Friends Lane |
Suite 400 |
Newtown,
PA
18940
|
|
Applicant Contact |
Paul Phillips |
Correspondent |
Regulatory Strategies, Inc |
808 E. Fox Lane |
Fox Point,
WI
53217
|
|
Correspondent Contact |
Mark Kramer |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 09/22/2014 |
Decision Date | 03/27/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|