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

    HOMMED SENTRY III PATIENT MONITOR SYSTEM

    K Number: K004044 · Decision Mar 2, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    8
    Review Days
    63

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    Basic Information

    Device Name
    HOMMED SENTRY III PATIENT MONITOR SYSTEM
    K Number
    K004044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hommed, LLC
    Date Received
    December 29, 2000
    Decision Date
    March 2, 2001
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQA Oximeter

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    Other Clearances by Hommed, LLC

    K Number Device Name
    K040799 HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS
    K040651 HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM
    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
    K993938 THE HOMMED SENTRY, MODEL 1 SENTRY