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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number870.1025
Classification Product Code
DSI  
Date Received01/30/1997
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
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