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

    ULTRASOUND TRANSDUCER DRAPE

    K Number: K970893 · Decision Oct 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    9
    Review Days
    223

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    Basic Information

    Device Name
    ULTRASOUND TRANSDUCER DRAPE
    K Number
    K970893
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Protek Medical Products, Inc.
    Date Received
    March 11, 1997
    Decision Date
    October 20, 1997
    Product Code
    FYA
    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
    FYA Gown, Surgical

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    Other Clearances by Protek Medical Products, Inc.

    K Number Device Name
    K973958 GENERAL PURPOSE ATL NEEDLE GUIDE KIT
    K973622 TRANSDUCER POSITIONER
    K970889 ULTRASOUND TRANSDUCER DRAPE
    K973362 NEEDLE GUIDE/GRID
    K970885 ULTRASOUND SYSTEMS DRAPE
    K970891 DRAPE, SURGICAL-LATEX
    K971722 TRANS VAGINAL NEEDLE GUIDE
    K971115 GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE