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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K874885
Device Name LAWRENCE L3000 CARDIAC OUTPUT MONITOR
Applicant
Lawrence Medical Systems, Inc.
1100 Avenida Acaso
Cammarillo,  CA  93010
Applicant Contact DONALD R STEELE
Correspondent
Lawrence Medical Systems, Inc.
1100 Avenida Acaso
Cammarillo,  CA  93010
Correspondent Contact DONALD R STEELE
Regulation Number870.2100
Classification Product Code
DPW  
Date Received12/01/1987
Decision Date 02/05/1988
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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