Device Classification Name |
Computer, Diagnostic, Programmable
|
510(k) Number |
K091165 |
Device Name |
HORIZON XVU |
Applicant |
MENNEN MEDICAL LTD. |
4 HAYARDEN ST., YAVNE |
P.O.BOX 102 |
REHOVOT,
IL
76100
|
|
Applicant Contact |
IFAT OREN |
Correspondent |
MENNEN MEDICAL LTD. |
4 HAYARDEN ST., YAVNE |
P.O.BOX 102 |
REHOVOT,
IL
76100
|
|
Correspondent Contact |
IFAT OREN |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 04/22/2009 |
Decision Date | 08/07/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|