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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 K822821
Device Name GAMBRO BLOOD LEVEL DETECTOR LCS 10
Applicant
Gambro, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Gambro, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.4340
Classification Product Code
DTW  
Date Received09/20/1982
Decision Date 10/18/1982
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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