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

    MINIOX 100 PULSE OXIMETER

    K Number: K862798 · Decision Aug 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    9
    Review Days
    36

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    Basic Information

    Device Name
    MINIOX 100 PULSE OXIMETER
    K Number
    K862798
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Catalyst Research Corp.
    Date Received
    July 23, 1986
    Decision Date
    August 28, 1986
    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 Catalyst Research Corp.

    K Number Device Name
    K905310 MINIOX V PULSE OXIMETER
    K874132 MINIOX IV PORTABLE PULSE OXIMETER
    K833995 MINI OX II
    K833326 MINI OX III OXYGEN MONITOR
    K790785 MODEL M25RL, (CRC) OXYGEN ANALYZER
    K790784 MODEL M25R, OXYGEN ANALYZER
    K782062 ANALYZER, OXYGEN MODEL M25RA & M25RAD
    K781746 MINICO