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

    MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET

    K Number: K133923 · Decision Apr 11, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    73
    Applicant Total
    5
    Review Days
    109

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    Basic Information

    Device Name
    MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET
    K Number
    K133923
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reflectance Medical, Inc.
    Date Received
    December 23, 2013
    Decision Date
    April 11, 2014
    Product Code
    MUD
    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
    MUD Oximeter, Tissue Saturation

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    Other Clearances by Reflectance Medical, Inc.

    K Number Device Name
    K141496 MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER
    K130079 MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER
    K122645 MOBILE CAREGUIDE 2100 OXIMETER
    K113656 CAREGUIDE OXIMETER