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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 K063111
Device Name FINOMETER MODEL-2 WITH ACCESSORIES
Applicant
Finapres Medical Systems B.V.
Paasheuvelweg 34a
Amsterdam Zo,  NL NL-1105
Applicant Contact GERAD J LANGEWOUTERS
Correspondent
Kema Quality B.V.
4377 County Line Rd.
Chalfont,  PA  18914
Correspondent Contact PATRICIA L MURPHY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/11/2006
Decision Date 02/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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