PulsioFlex Monitoring System— 510(k) K172259

Clearance details

Applicant

Pulsion Medical Systems SE

Product code

Code DXG

Device class

Class 2

Regulation

21 CFR 870.1435

Advisory panel

Cardiovascular

Date received

2017-07-27

Decision date

2018-01-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Feldkirchen, DE

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• Z-2077-2019 — PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed. ¿ -With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters. -With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption. The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital unitsClass II·Terminated·GETINGE US SALES LLC·20190605

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172259.