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

    HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM

    K Number: K040651 · Decision Aug 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    420
    Registration Numbers
    420
    Same Product Code
    1186
    Applicant Total
    8
    Review Days
    152

    Basic Information

    Device Name
    HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM
    K Number
    K040651
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HOMMED LLC.
    Date Received
    March 11, 2004
    Decision Date
    August 10, 2004
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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    Other Clearances by HOMMED LLC.

    K Number Device Name
    K040799 HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS
    K040032 CENTRAL STATION, VERSION 3.3H
    K020184 HOMMED CENTRAL STATION
    K014025 HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER
    K003180 HOMMED OBSERVER, MODEL I
    K004044 HOMMED SENTRY III PATIENT MONITOR SYSTEM
    K993938 THE HOMMED SENTRY, MODEL 1 SENTRY