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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Fetal Doppler

    K Number: K142769 · Decision Mar 20, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    176

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    Basic Information

    Device Name
    Fetal Doppler
    K Number
    K142769
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Icare Newlife Technologies, Inc.
    Date Received
    September 25, 2014
    Decision Date
    March 20, 2015
    Product Code
    HEK
    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
    HEK Monitor, Heart Sound, Fetal, Ultrasonic

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