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

    SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX

    K Number: K031849 · Decision Sep 9, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    136
    Review Days
    85

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    Basic Information

    Device Name
    SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX
    K Number
    K031849
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datascope Corp.
    Date Received
    June 16, 2003
    Decision Date
    September 9, 2003
    Product Code
    MHX
    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
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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