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

    BIOFUSIONARY BEBE

    K Number: K121123 · Decision Mar 10, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    44
    Applicant Total
    1
    Review Days
    696

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    Basic Information

    Device Name
    BIOFUSIONARY BEBE
    K Number
    K121123
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5290
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rocky Mountain Biosystems, Inc.
    Date Received
    April 13, 2012
    Decision Date
    March 10, 2014
    Product Code
    IMJ
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

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