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

    EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE

    K Number: K890637 · Decision Jun 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    29
    Applicant Total
    94
    Review Days
    124

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    Basic Information

    Device Name
    EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE
    K Number
    K890637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2225
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Elscint, Inc.
    Date Received
    February 8, 1989
    Decision Date
    June 12, 1989
    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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    K980306 GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP
    K974614 GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102
    K972592 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
    K970680 GLORY
    K965044 GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102
    K970980 CARDIAC SCORING FOR CT SCANNERS
    K970005 GYREX 2T-PRESTIGE
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