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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 -3350
Applicant Contact JILL BARNEY
Correspondent
Sorba Medical Systems, Inc.
8324 N. Steven Rd.
Milwaukee,  WI  53223 -3350
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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