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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gas-machine, anesthesia
510(k) Number K001315
Device Name MODIFICATION TO KION ANESTHESIA SYSTEM
Applicant
SIEMENS ELEMA AB
ELECTROMEDICAL SYSTEMS GROUP
16 ELECTRONICS AVENUE
DANVERS,  MA  01923
Applicant Contact DAVE SIMARD
Correspondent
SIEMENS ELEMA AB
ELECTROMEDICAL SYSTEMS GROUP
16 ELECTRONICS AVENUE
DANVERS,  MA  01923
Correspondent Contact DAVE SIMARD
Regulation Number868.5160
Classification Product Code
BSZ  
Subsequent Product Code
MHX  
Date Received04/26/2000
Decision Date 05/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
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