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

    DRG REACTION CHAMBER/SAFETY TIP

    K Number: K012003 · Decision Feb 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    13
    Review Days
    230

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    Basic Information

    Device Name
    DRG REACTION CHAMBER/SAFETY TIP
    K Number
    K012003
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Doctor'S Research Group, Inc.
    Date Received
    June 27, 2001
    Decision Date
    February 12, 2002
    Product Code
    HEI
    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
    HEI Monitor, Heart-Valve Movement, Fetal, Ultrasonic

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