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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 K024213
Device Name SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655
Applicant
Siemens Medical Solutions USA, Inc.
186 S. Wood Ave.
Iselin,  NJ  08830
Applicant Contact JAMIE YIEH
Correspondent
Siemens Medical Solutions USA, Inc.
186 S. Wood Ave.
Iselin,  NJ  08830
Correspondent Contact JAMIE YIEH
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Code
BSZ  
Date Received12/20/2002
Decision Date 03/23/2004
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
Recalls CDRH Recalls
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