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

    IMPULSE 3000 DEFIBRILLATOR ANALYZER

    K Number: K934254 · Decision Nov 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    18
    Applicant Total
    6
    Review Days
    84

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    Basic Information

    Device Name
    IMPULSE 3000 DEFIBRILLATOR ANALYZER
    K Number
    K934254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5325
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dynatech/Nevada, Inc.
    Date Received
    August 31, 1993
    Decision Date
    November 23, 1993
    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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