Device Classification Name |
Detector And Alarm, Arrhythmia
|
510(k) Number |
K141441 |
Device Name |
MENNTOR X7 |
Applicant |
MENNEN MEDICAL LTD. |
4 HA-YARDEN ST. YAVNE 8122804 |
P.O. BOX 102 REHOVOT 7610002 |
YAVNE,
IL
8122804
|
|
Applicant Contact |
IFAT SHWARTS |
Correspondent |
MENNEN MEDICAL LTD. |
4 HA-YARDEN ST. YAVNE 8122804 |
P.O. BOX 102 REHOVOT 7610002 |
YAVNE,
IL
8122804
|
|
Correspondent Contact |
IFAT SHWARTS |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 06/02/2014 |
Decision Date | 01/09/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|