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

    ALTADYNE

    K Number: K953675 · Decision Sep 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    101
    Applicant Total
    8
    Review Days
    52

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    Basic Information

    Device Name
    ALTADYNE
    K Number
    K953675
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5550
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lumex, Inc.
    Date Received
    August 7, 1995
    Decision Date
    September 28, 1995
    Product Code
    FNM
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FNM Mattress, Air Flotation, Alternating Pressure

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