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

    EM-SCAN HP-2 PEDIATRIC BODY COMPOSITION ANALYZER

    K Number: K902042 · Decision Jul 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    113
    Applicant Total
    1
    Review Days
    83

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    Basic Information

    Device Name
    EM-SCAN HP-2 PEDIATRIC BODY COMPOSITION ANALYZER
    K Number
    K902042
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2770
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Em-Scan, Inc.
    Date Received
    May 4, 1990
    Decision Date
    July 26, 1990
    Product Code
    DSB
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DSB Plethysmograph, Impedance

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