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

    OXICARE FINGERTIP PULSE OXIMETER

    K Number: K133090 · Decision Feb 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    7
    Review Days
    151

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    Basic Information

    Device Name
    OXICARE FINGERTIP PULSE OXIMETER
    K Number
    K133090
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Delbio Incorporation
    Date Received
    September 30, 2013
    Decision Date
    February 28, 2014
    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 Delbio Incorporation

    K Number Device Name
    K132338 DA01 BLOOD GLUCOSE MONITORING SYSTEM
    K130244 DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
    K120866 DA01 BLOOD GLUCOSE MONITORING SYSTEM
    K103329 DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION
    K113343 DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM
    K100806 DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM