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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K030738
Device Name SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
Applicant
Siemens Medical Solutions USA, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Applicant Contact PENELOPE H GRECO
Correspondent
Siemens Medical Solutions USA, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact PENELOPE H GRECO
Regulation Number870.1025
Classification Product Code
MHX  
Date Received03/10/2003
Decision Date 06/06/2003
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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