FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1

System, Measurement, Blood-pressure, Non-invasive

FMS, FINAPRES MEDICAL SYSTEMS BV

The following data is part of a premarket notification filed by Fms, Finapres Medical Systems Bv with the FDA for Finometer Noninvasive Hemodynamic Monitor, Model 1.

Pre-market Notification Details

Device IDK023723
510k NumberK023723
Device Name:FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant FMS, FINAPRES MEDICAL SYSTEMS BV 1205 DE LA VINA ST. Santa Barbara,  CA  93101
ContactChristine Emanuel
CorrespondentChristine Emanuel
FMS, FINAPRES MEDICAL SYSTEMS BV 1205 DE LA VINA ST. Santa Barbara,  CA  93101
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-05
Decision Date2003-10-23
Summary:summary

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