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

    OMRON MODEL HBP-2070 VITAL SIGNS MONITOR

    K Number: K082812 · Decision Oct 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    68
    Review Days
    28

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    Basic Information

    Device Name
    OMRON MODEL HBP-2070 VITAL SIGNS MONITOR
    K Number
    K082812
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omron Healthcare, Inc.
    Date Received
    September 24, 2008
    Decision Date
    October 22, 2008
    Product Code
    MWI
    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
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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