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

    MEDICAL COMPRESSOR, MODELS DK50 D AND DM

    K Number: K060781 · Decision Oct 3, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    73
    Applicant Total
    2
    Review Days
    195

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    Basic Information

    Device Name
    MEDICAL COMPRESSOR, MODELS DK50 D AND DM
    K Number
    K060781
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.6250
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ekom S.R.O.
    Date Received
    March 22, 2006
    Decision Date
    October 3, 2006
    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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