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

    IMPACT MODEL 601

    K Number: K841537 · Decision May 31, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    73
    Applicant Total
    27
    Review Days
    45

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    Basic Information

    Device Name
    IMPACT MODEL 601
    K Number
    K841537
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.6250
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Impact Instrumentation, Inc.
    Date Received
    April 16, 1984
    Decision Date
    May 31, 1984
    Product Code
    BTI
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTI Compressor, Air, Portable

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