Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K142476 |
Device Name |
Master Caution Device MCD |
Applicant |
HealthWatch Ltd. |
6 Hasadna Street |
kfar saba,
IL
44424
|
|
Applicant Contact |
yoram levy |
Correspondent |
QSITE |
31 HAAVODA STREET |
binyamina,
IL
30500
|
|
Correspondent Contact |
yoram levy |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 09/03/2014 |
Decision Date | 02/17/2015 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|