BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent for Some Indications 🇸🇪 Sweden

    NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)

    K Number: K862364 · Decision Aug 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    29
    Applicant Total
    2
    Review Days
    56

    Basic Information

    Device Name
    NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)
    K Number
    K862364
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2225
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    SWEMED LABORATORIES, INC.
    Date Received
    June 24, 1986
    Decision Date
    August 19, 1986
    Product Code
    HEM
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HEM Imager, Ultrasonic Obstetric-Gynecologic

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    Other Clearances by SWEMED LABORATORIES, INC.

    K Number Device Name
    K862365 NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE