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

    DMS 300-7

    K Number: K062007 · Decision Aug 16, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    193
    Applicant Total
    5
    Review Days
    30

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    Basic Information

    Device Name
    DMS 300-7
    K Number
    K062007
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnostic Monitoring Software
    Date Received
    July 17, 2006
    Decision Date
    August 16, 2006
    Product Code
    DSH
    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
    DSH Recorder, Magnetic Tape, Medical

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    Other Clearances by Diagnostic Monitoring Software

    K Number Device Name
    K133014 DMS 300-2W HOLTER ECG RECORDER
    K062959 DMS 300-2, 300-3 AND 300-4
    K062088 PREMIER 11 HOLTER
    K911615 HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300