Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K093766 |
Device Name |
VITALOGIK 6000/6500 |
Applicant |
MENNEN MEDICAL LTD. |
4 HA-YARDEN ST. |
P.O. BOX 102 |
YAVNE, REHOVOT,
IL
76100
|
|
Applicant Contact |
IFAT OREN SHWARTS |
Correspondent |
MENNEN MEDICAL LTD. |
4 HA-YARDEN ST. |
P.O. BOX 102 |
YAVNE, REHOVOT,
IL
76100
|
|
Correspondent Contact |
IFAT OREN SHWARTS |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 12/07/2009 |
Decision Date | 05/07/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|