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

    MODEL MSC SA02-5000 PULSE OXIMETER

    K Number: K902192 · Decision Aug 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    8
    Review Days
    99

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    Basic Information

    Device Name
    MODEL MSC SA02-5000 PULSE OXIMETER
    K Number
    K902192
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medical Systems Corp.
    Date Received
    May 16, 1990
    Decision Date
    August 23, 1990
    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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