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

    502-US PULSE OXIMETER

    K Number: K875298 · Decision Mar 7, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    22
    Review Days
    68

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    Basic Information

    Device Name
    502-US PULSE OXIMETER
    K Number
    K875298
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Criticare Systems, Inc.
    Date Received
    December 30, 1987
    Decision Date
    March 7, 1988
    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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