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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 K852514
Device Name MODEL 78560A CENTRAL STATION PATIENT INFO SYS
Applicant
HEWLETT-PACKARD CO.
175 WALTHAM ST.
P.O.BOX 9030
WALTHAM,  MA  02254
Applicant Contact NICHOLAS POLY
Correspondent
HEWLETT-PACKARD CO.
175 WALTHAM ST.
P.O.BOX 9030
WALTHAM,  MA  02254
Correspondent Contact NICHOLAS POLY
Regulation Number870.1025
Classification Product Code
DSI  
Date Received06/12/1985
Decision Date 09/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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