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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 K933177
Device Name SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS,  MA  01923
Applicant Contact ROBERT MURFITT
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS,  MA  01923
Correspondent Contact ROBERT MURFITT
Regulation Number870.1025
Classification Product Code
DSI  
Date Received06/30/1993
Decision Date 04/10/1995
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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