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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 K962291
Device Name SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
Applicant
Siemens Medical Solutions USA, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Applicant Contact Jacqueline Emery
Correspondent
Siemens Medical Solutions USA, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact Jacqueline Emery
Regulation Number870.1025
Classification Product Code
DSI  
Date Received06/14/1996
Decision Date 01/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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