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

    BABYCARE

    K Number: K023082 · Decision Mar 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    3
    Applicant Total
    3
    Review Days
    167

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    Basic Information

    Device Name
    BABYCARE
    K Number
    K023082
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bionet Company, Ltd.
    Date Received
    September 17, 2002
    Decision Date
    March 3, 2003
    Product Code
    HEP
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HEP Monitor, Blood-Flow, Ultrasonic

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    Other Clearances by Bionet Company, Ltd.

    K Number Device Name
    K023034 CARDIOTOUCH-3000
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