BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Pulsioflex Monitoring System with PiCCO Module

    Reg #: 3003263092 · FEI: 3003263092 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PULSION MEDICAL SYSTEMS SE
    Registration Number
    3003263092
    FEI Number
    3003263092
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hans-Riedl-Strasse 17
    City
    Feldkirchen Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K122121

    Owner / Operator

    Firm Name
    Maquet Critical Care AB
    Operator Number
    9036213
    Address
    ROENTGENVAGEN 2
    City
    Solna
    State
    SE-NOTA
    Postal Code
    SE-17154
    Country
    SE

    Products

    Device Name Product Code
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG

    Proprietary Names

    Pulsioflex Monitoring System with PiCCO Module PC4510 Pulsioflex Pulsioflex Monitoring System PC4000

    Establishment Types

    Manufacture Medical Device