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

    DR300 HOLTER MONITOR

    K Number: K142424 · Decision Nov 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    59
    Applicant Total
    10
    Review Days
    88

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    Basic Information

    Device Name
    DR300 HOLTER MONITOR
    K Number
    K142424
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    North East Monitoring, Inc.
    Date Received
    August 29, 2014
    Decision Date
    November 25, 2014
    Product Code
    MWJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MWJ Electrocardiograph, Ambulatory (Without Analysis)

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    Other Clearances by North East Monitoring, Inc.

    K Number Device Name
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    K061293 TELAHEART DIGITAL RECORDER
    K041901 SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER
    K004007 DR180+OXY
    K001288 DR180-II
    K983576 DR180-R/OXY
    K960925 NORTHEAST MONITORING DR180
    K930564 HOLTER FOR WINDOWS