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

    WITT BIOMEDICAL VX-80

    K Number: K880258 · Decision Jun 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    176
    Applicant Total
    6
    Review Days
    146

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    Basic Information

    Device Name
    WITT BIOMEDICAL VX-80
    K Number
    K880258
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1435
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Witt Biomedical Corporation
    Date Received
    January 22, 1988
    Decision Date
    June 16, 1988
    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

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    Other Clearances by Witt Biomedical Corporation

    K Number Device Name
    K010058 IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK
    K973474 WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS
    K950436 WITT BIOMEDICAL SERIES IV
    K945582 WITT BIOMEDICAL IMAGE III
    K923054 WITT BIOMEDICAL SERIES II-EP