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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 K884991
Device Name CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN
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 Number868.5160
Classification Product Code
BSZ  
Date Received12/01/1988
Decision Date 06/06/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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