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

    CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM

    K Number: K063547 · Decision Dec 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    5
    Review Days
    27

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    Basic Information

    Device Name
    CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM
    K Number
    K063547
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Witt Biomedical Corp
    Date Received
    November 24, 2006
    Decision Date
    December 21, 2006
    Product Code
    MWI
    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
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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    Other Clearances by Witt Biomedical Corp

    K Number Device Name
    K101571 XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS
    K063840 XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION
    K040195 CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM
    K033030 CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM