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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K950389
Device Name SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR
Applicant
Sorba Medical Systems, Inc.
8324 N. Steven Rd.
Milwaukee,  WI  53223
Applicant Contact JILL BARNEY
Correspondent
Sorba Medical Systems, Inc.
8324 N. Steven Rd.
Milwaukee,  WI  53223
Correspondent Contact JILL BARNEY
Regulation Number870.2770
Classification Product Code
DSB  
Date Received02/01/1995
Decision Date 08/15/1995
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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