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

    APEX OXIMETER

    K Number: K980299 · Decision Apr 24, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    9
    Review Days
    87

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    Basic Information

    Device Name
    APEX OXIMETER
    K Number
    K980299
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Marquette Medical Systems, Inc.
    Date Received
    January 27, 1998
    Decision Date
    April 24, 1998
    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 Marquette Medical Systems, Inc.

    K Number Device Name
    K993008 QUANTITATIVE SENTINEL SYSTEM
    K981024 QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM)
    K980495 MUSE CARDIOVASCULAR INFORMATION SYSTEM
    K980582 MULTI-LINK CABLE AND LEAD WIRE SYSTEMS
    K973403 CARDIOSMART ST
    K974199 ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION
    K973984 RAC 2A MODULE HOUSING
    K970545 DASH 1000 PATIENT MONITOR