FMS, Finapres Medical Systems BV

FDA Regulatory Profile

FMS, Finapres Medical Systems BV appears in FDA public data with 1 recall, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2150-2012, Class II) was initiated on July 6, 2012. Its most recent 510(k) clearance was granted on October 23, 2003.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2150-2012Class IIFinapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure July 6, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K023723FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1October 23, 2003
K023338PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2May 9, 2003