BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST

    K Number: K913358 · Decision Dec 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    176
    Applicant Total
    20
    Review Days
    144

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST
    K Number
    K913358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1435
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ppg Industries, Inc.
    Date Received
    July 29, 1991
    Decision Date
    December 20, 1991
    Product Code
    DXG
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DXG), ordered by most recent decision date.

    Argos Infinity (Rev. 1.0)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VitalStream ART Connect; VitalStream-Hemo

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cogent™ Hemodynamic Monitoring System; Cogent™ HMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Hypotension Decision Assist Model HDA-OR2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PulsioFlex Monitoring System with ProAQT Sensor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EV1000 Clinical Platform

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Ppg Industries, Inc.

    K Number Device Name
    K922631 STATPAL II BLOOD GAS ANALYSIS SYSTEM
    K914560 STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPAL
    K912627 MIDAS SYSTEM 2500, PHYSIOLOGICAL MONITORING SYSTEM
    K903965 STATPAL BLOOD GAS MONITORING SYSTEM
    K901514 XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.
    K900246 CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512
    K901132 SARA SATCAP
    K896442 PPG BIOMEDICAL VENTILATOR MODEL IRISA
    K900700 SMU 611 UNIVERSALMONITOR
    K890875 CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512
    Search all 20 clearances from Ppg Industries, Inc. →