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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 K945384
Device Name 1481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED
Applicant
Siemens Medical Solutions USA, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Applicant Contact TOM CONNELLY
Correspondent
Siemens Medical Solutions USA, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact TOM CONNELLY
Regulation Number870.1025
Classification Product Code
DSI  
Date Received11/03/1994
Decision Date 05/10/1995
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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