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

    WITT BIOMEDICAL SERIES IV

    K Number: K950436 · Decision Nov 2, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    6
    Review Days
    273

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    Basic Information

    Device Name
    WITT BIOMEDICAL SERIES IV
    K Number
    K950436
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Witt Biomedical Corporation
    Date Received
    February 2, 1995
    Decision Date
    November 2, 1995
    Product Code
    MHX
    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
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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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
    K945582 WITT BIOMEDICAL IMAGE III
    K923054 WITT BIOMEDICAL SERIES II-EP
    K880258 WITT BIOMEDICAL VX-80