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

    ZYMED HOLTER SCANNER MODEL 2010

    K Number: K955015 · Decision Mar 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    403
    Applicant Total
    7
    Review Days
    138

    Basic Information

    Device Name
    ZYMED HOLTER SCANNER MODEL 2010
    K Number
    K955015
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ZYMED MEDICAL INSTRUMENTATION
    Date Received
    November 1, 1995
    Decision Date
    March 18, 1996
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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