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

    DURA NEB(TM) 2000 PORTABLE COMPRESSOR

    K Number: K863339 · Decision Oct 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    73
    Applicant Total
    1
    Review Days
    40

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    Basic Information

    Device Name
    DURA NEB(TM) 2000 PORTABLE COMPRESSOR
    K Number
    K863339
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.6250
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Thera Tec, Inc.
    Date Received
    August 28, 1986
    Decision Date
    October 7, 1986
    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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