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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 K010923
Device Name KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
Applicant
SIEMENS ELEMA AB
MEDICAL SOLUTIONS
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830 -2770
Applicant Contact DIANE WURZBURGER
Correspondent
SIEMENS ELEMA AB
MEDICAL SOLUTIONS
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830 -2770
Correspondent Contact DIANE WURZBURGER
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Code
BSZ  
Date Received03/27/2001
Decision Date 01/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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