Device Classification Name |
Detector And Alarm, Arrhythmia
|
510(k) Number |
K970358 |
Device Name |
ENSEMBLE CENTRAL STATION MONITOR |
Applicant |
MENNEN MEDICAL, INC. |
KIRYAT WEIZMANN SCIENCE PARK |
P.O. BOX 102 |
REHOVOT,
IL
76100
|
|
Applicant Contact |
ALAN SCHWEBEL PH.D. |
Correspondent |
MENNEN MEDICAL, INC. |
KIRYAT WEIZMANN SCIENCE PARK |
P.O. BOX 102 |
REHOVOT,
IL
76100
|
|
Correspondent Contact |
ALAN SCHWEBEL PH.D. |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 01/30/1997 |
Decision Date | 02/11/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|