Device Classification Name |
outpatient cardiac telemetry
|
510(k) Number |
K020632 |
Device Name |
ENGUARD REMOTE PATIENT MONITOR |
Applicant |
MENNEN MEDICAL LTD. |
KIRYAT WEIZMANN SCIENCE PARK |
P.O. BOX 102 |
REHOVOT,
IL
76100
|
|
Applicant Contact |
EREZ NIMROD |
Correspondent |
MENNEN MEDICAL LTD. |
KIRYAT WEIZMANN SCIENCE PARK |
P.O. BOX 102 |
REHOVOT,
IL
76100
|
|
Correspondent Contact |
EREZ NIMROD |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/27/2002 |
Decision Date | 03/15/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|