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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 K904355
Device Name CARDIOCAP II TM CH-RESP MONITORS
Applicant
Instrumentarium Corp.
Teollisuuskatu 27
00510 Helsinki 51
Finland,  FI
Applicant Contact HANNU AHJOPALO
Correspondent
Instrumentarium Corp.
Teollisuuskatu 27
00510 Helsinki 51
Finland,  FI
Correspondent Contact HANNU AHJOPALO
Regulation Number870.2340
Classification Product Code
DPS  
Date Received09/24/1990
Decision Date 05/23/1991
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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