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

    ZYBIT

    K Number: K002004 · Decision Sep 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    7
    Review Days
    80

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    Basic Information

    Device Name
    ZYBIT
    K Number
    K002004
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zymed Medical Instrumentation
    Date Received
    July 3, 2000
    Decision Date
    September 21, 2000
    Product Code
    DXH
    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
    DXH Transmitters And Receivers, Electrocardiograph, Telephone

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    Other Clearances by Zymed Medical Instrumentation

    K Number Device Name
    K992197 MODIFICATION TO ZYMED HOLTER 2000
    K990170 HOLTER 2000
    K984089 ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW
    K955015 ZYMED HOLTER SCANNER MODEL 2010
    K951370 ZYMED TELEMETRY SYSTEM; MODEL T8010
    K930894 MULTITRAK-PLUS