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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echocardiograph
510(k) Number K851426
Device Name ACCUCOM CARDIAC OUTPUT MONITOR
Applicant
Lawrence Medical Systems, Inc.
14910 NE 31st Cir.
Redmond,  WA  98052
Applicant Contact RODNEY T CARLISLE
Correspondent
Lawrence Medical Systems, Inc.
14910 NE 31st Cir.
Redmond,  WA  98052
Correspondent Contact RODNEY T CARLISLE
Regulation Number870.2330
Classification Product Code
DXK  
Date Received04/10/1985
Decision Date 07/12/1985
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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