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

    FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01

    K Number: K862072 · Decision Jul 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    35
    Applicant Total
    5
    Review Days
    40

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01
    K Number
    K862072
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2960
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    International Biomedics, Inc.
    Date Received
    May 30, 1986
    Decision Date
    July 9, 1986
    Product Code
    HGL
    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
    HGL Transducer, Ultrasonic, Obstetric

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HGL), ordered by most recent decision date.

    ULTRASOUND TRANSDUCER, MODEL US917

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OP3/VP4

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ULTRASONIC PULSED DOPPLER IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by International Biomedics, Inc.

    K Number Device Name
    K031096 MODIFICATION TO TRANSPORT INCUBATOR 185
    K860933 AIR-CUSHION TOCOTONOMETER
    K860295 FETASCAN 1500
    K852439 FETA SCAN 1000 OBSTETRICAL IMAGER