Device Classification Name |
Computer, Diagnostic, Programmable
|
510(k) Number |
K070254 |
Device Name |
HORIZON SE |
Applicant |
MENNEN MEDICAL LTD. |
4 HAYARDEN ST. |
P.O. BOX 102 REHOVOT |
YAVNE,
IL
76100
|
|
Applicant Contact |
MICHA OESTEREICH |
Correspondent |
MENNEN MEDICAL LTD. |
4 HAYARDEN ST. |
P.O. BOX 102 REHOVOT |
YAVNE,
IL
76100
|
|
Correspondent Contact |
MICHA OESTEREICH |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 01/26/2007 |
Decision Date | 04/19/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|