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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer, diagnostic, programmable
510(k) Number K002137
Device Name CATHCOR DESKTOP
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 Number870.1425
Classification Product Code
DQK  
Date Received07/14/2000
Decision Date 10/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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