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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, St Segment With Alarm
510(k) Number K920429
Device Name MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM
Applicant
HEWLETT-PACKARD CO.
175 WALTHAM ST.
P.O.BOX 9030
WALTHAM,  MA  02254
Applicant Contact DAVID OSBORN
Correspondent
HEWLETT-PACKARD CO.
175 WALTHAM ST.
P.O.BOX 9030
WALTHAM,  MA  02254
Correspondent Contact DAVID OSBORN
Regulation Number870.1025
Classification Product Code
MLD  
Date Received02/03/1992
Decision Date 07/20/1993
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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