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

    HUNTLEIGH DOPCORD, D140

    K Number: K854267 · Decision Jul 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    59
    Applicant Total
    23
    Review Days
    259

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    Basic Information

    Device Name
    HUNTLEIGH DOPCORD, D140
    K Number
    K854267
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Huntleigh Technology, Inc.
    Date Received
    October 23, 1985
    Decision Date
    July 9, 1986
    Product Code
    KNG
    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
    KNG Monitor, Ultrasonic, Fetal

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    Other Clearances by Huntleigh Technology, Inc.

    K Number Device Name
    K992733 AKRON ATP9 TRACTION MACHINE
    K964699 RHEO DOPPLEX II (RD 2)
    K924516 OP3/VP4
    K910188 FLOWPLUS AC330 PUMP GARMENTS
    K900882 MULTI DOPPLEX, MD-1
    K900618 HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140
    K890012 HUNTLEIGH DYNAMIC FLOTATION SYSTEM
    K884451 DOPCORD PPG
    K881632 FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT
    K874688 FLOWTRON AC200/2
    Search all 23 clearances from Huntleigh Technology, Inc. →