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

    MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE

    K Number: K030547 · Decision Jul 11, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    18
    Applicant Total
    5
    Review Days
    141

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    Basic Information

    Device Name
    MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE
    K Number
    K030547
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5325
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guardian Angel Products, Inc.
    Date Received
    February 20, 2003
    Decision Date
    July 11, 2003
    Product Code
    DRL
    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
    DRL Tester, Defibrillator

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