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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Console, Heart-Lung Machine, Cardiopulmonary Bypass
510(k) Number K842138
Device Name COBE EMERGENCY POWER SOURCE 43610-000
Applicant
Cobe Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Cobe Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received05/30/1984
Decision Date 08/03/1984
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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