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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 K946306
Device Name SIEMENS SC 9000 BEDSIDE MONITOR, SC 9015 BEDSIDE MOINTORING SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS,  MA  01923
Applicant Contact THOMAS CONNELLY
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS,  MA  01923
Correspondent Contact THOMAS CONNELLY
Regulation Number870.1025
Classification Product Code
DSI  
Date Received12/28/1994
Decision Date 06/27/1995
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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