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

    HOLTER FOR WINDOWS

    K Number: K930564 · Decision Apr 19, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    10
    Review Days
    805

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    Basic Information

    Device Name
    HOLTER FOR WINDOWS
    K Number
    K930564
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    North East Monitoring, Inc.
    Date Received
    February 3, 1993
    Decision Date
    April 19, 1995
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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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
    K983576 DR180-R/OXY
    K960925 NORTHEAST MONITORING DR180