Pulsion Medical Systems SE

FDA Regulatory Profile

Pulsion Medical Systems SE appears in FDA public data with 0 recalls, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on April 30, 2020.

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K192169PulsioFlex Monitoring System with ProAQT SensorApril 30, 2020
K171620PiCCO CatheterFebruary 21, 2018
K172259PulsioFlex Monitoring SystemJanuary 18, 2018
K122121PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULEAugust 2, 2012