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

    PETIT SOPHIA

    K Number: K021978 · Decision Apr 8, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    23
    Applicant Total
    2
    Review Days
    295

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PETIT SOPHIA
    K Number
    K021978
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nishitomo Co., Inc.
    Date Received
    June 17, 2002
    Decision Date
    April 8, 2003
    Product Code
    LHD
    Advisory Committee
    Unknown
    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
    LHD Device, Fertility Diagnostic, Proceptive

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LHD), ordered by most recent decision date.

    Ava Fertility Tracker

    FDA 510(k)
    FDA Unclassified ·Unknown

    OVUSENSE

    FDA 510(k)
    FDA Unclassified ·Unknown

    DUOFERTILITY

    FDA 510(k)
    FDA Unclassified ·Unknown

    LADY COMP USA

    FDA 510(k)
    FDA Unclassified ·Unknown

    MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921

    FDA 510(k)
    FDA Unclassified ·Unknown

    TCOYF FERTILITY SOFTWARE VERSION 1.0

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Nishitomo Co., Inc.

    K Number Device Name
    K901512 L SOPHIA