510(k) K023338

PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 by Fms, Finapres Medical Systems BV — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2003
Date Received
October 7, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type