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

    Z VIEW METER MODEL 300

    K Number: K830823 · Decision May 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    64

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    Basic Information

    Device Name
    Z VIEW METER MODEL 300
    K Number
    K830823
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2370
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Lintronics Industries, Inc.
    Date Received
    March 15, 1983
    Decision Date
    May 18, 1983
    Product Code
    KRC
    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
    KRC Tester, Electrode, Surface, Electrocardiographic

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