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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
510(k) Number K915337
Device Name CAPIOX LEVEL ALARM
Applicant
Terumo Medical Corp.
P.O. Box 605
Elkton,  MD  21912
Applicant Contact SANDI HARTKA
Correspondent
Terumo Medical Corp.
P.O. Box 605
Elkton,  MD  21912
Correspondent Contact SANDI HARTKA
Regulation Number870.4340
Classification Product Code
DTW  
Date Received11/26/1991
Decision Date 02/21/1992
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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