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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K023723
Device Name FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1
Applicant
Fms, Finapres Medical Systems BV
1205 De La Vina St.
Santa Barbara,  CA  93101
Applicant Contact CHRISTINE EMANUEL
Correspondent
Fms, Finapres Medical Systems BV
1205 De La Vina St.
Santa Barbara,  CA  93101
Correspondent Contact CHRISTINE EMANUEL
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
DSB  
Date Received11/05/2002
Decision Date 10/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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