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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K884956
Device Name CARDIOCAP(TM) CTO-104 MONITOR
Applicant
Datex Division Instrumentarium Corp.
P.O. Box 446
Sf-00101
Helsinki, Finland,  FI
Applicant Contact HANNU AHJOPALO
Correspondent
Datex Division Instrumentarium Corp.
P.O. Box 446
Sf-00101
Helsinki, Finland,  FI
Correspondent Contact HANNU AHJOPALO
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/29/1988
Decision Date 12/27/1988
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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