Device Classification Name |
Transmitters And Receivers, Electrocardiograph, Telephone
|
510(k) Number |
K113514 |
Device Name |
SMARTHEART |
Applicant |
SHL TELEMEDICINE INTERNATIONAL LTD. |
31 HAAVODA ST. |
BINYAMINA,
IL
30500
|
|
Applicant Contact |
YORAM LEVY |
Correspondent |
SHL TELEMEDICINE INTERNATIONAL LTD. |
31 HAAVODA ST. |
BINYAMINA,
IL
30500
|
|
Correspondent Contact |
YORAM LEVY |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 11/28/2011 |
Decision Date | 02/22/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|