BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DERMATHERAPY, MODEL 22216

    K Number: K061242 · Decision Jan 25, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    210
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    267

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    Basic Information

    Device Name
    DERMATHERAPY, MODEL 22216
    K Number
    K061242
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6190
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Precision Fabrics Group, Inc.
    Date Received
    May 3, 2006
    Decision Date
    January 25, 2007
    Product Code
    FMW
    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
    FMW Cover, Mattress (Medical Purposes)

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