Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K071348 |
Device Name |
EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM |
Applicant |
MENNEN MEDICAL LTD. |
4 HA-YARDEN ST. |
P.O. BOX 102 |
YAVNE, REHOVOT,
IL
76100
|
|
Applicant Contact |
MICHA OESTEREICH |
Correspondent |
MENNEN MEDICAL LTD. |
4 HA-YARDEN ST. |
P.O. BOX 102 |
YAVNE, REHOVOT,
IL
76100
|
|
Correspondent Contact |
MICHA OESTEREICH |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 05/14/2007 |
Decision Date | 09/07/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|