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

    HOLTER 2000

    K Number: K990170 · Decision Apr 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    31
    Applicant Total
    7
    Review Days
    84

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    Basic Information

    Device Name
    HOLTER 2000
    K Number
    K990170
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zymed Medical Instrumentation
    Date Received
    January 19, 1999
    Decision Date
    April 13, 1999
    Product Code
    MLO
    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
    MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

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    Other Clearances by Zymed Medical Instrumentation

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    K955015 ZYMED HOLTER SCANNER MODEL 2010
    K951370 ZYMED TELEMETRY SYSTEM; MODEL T8010
    K930894 MULTITRAK-PLUS