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

    ULTRASOUND SYSTEMS DRAPE

    K Number: K970885 · Decision Sep 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    14
    Applicant Total
    9
    Review Days
    195

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    Basic Information

    Device Name
    ULTRASOUND SYSTEMS DRAPE
    K Number
    K970885
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Protek Medical Products, Inc.
    Date Received
    March 11, 1997
    Decision Date
    September 22, 1997
    Product Code
    MMP
    Advisory Committee
    General, Plastic Surgery
    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
    MMP Cover, Barrier, Protective

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