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

    DR180-R/OXY

    K Number: K983576 · Decision Mar 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    10
    Review Days
    161

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    Basic Information

    Device Name
    DR180-R/OXY
    K Number
    K983576
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    North East Monitoring, Inc.
    Date Received
    October 13, 1998
    Decision Date
    March 23, 1999
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FLL Continuous Measurement Thermometer

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    Other Clearances by North East Monitoring, Inc.

    K Number Device Name
    K142424 DR300 HOLTER MONITOR
    K081861 HOLTER LX ANALYSIS
    K070014 AUTO DETECT FOR TELAHEART DR200/E-A
    K061293 TELAHEART DIGITAL RECORDER
    K041901 SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER
    K004007 DR180+OXY
    K001288 DR180-II
    K960925 NORTHEAST MONITORING DR180
    K930564 HOLTER FOR WINDOWS