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

    LIFEDOP MODEL, L350R

    K Number: K090499 · Decision Mar 31, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    8
    Applicant Total
    7
    Review Days
    34

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    Basic Information

    Device Name
    LIFEDOP MODEL, L350R
    K Number
    K090499
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Summit Doppler Systems, Inc.
    Date Received
    February 25, 2009
    Decision Date
    March 31, 2009
    Product Code
    MAA
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    MAA Monitor, Fetal Doppler Ultrasound

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