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

    NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER

    K Number: K963400 · Decision Nov 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    42
    Review Days
    89

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    Basic Information

    Device Name
    NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER
    K Number
    K963400
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nellcor Puritan Bennett, Inc.
    Date Received
    August 29, 1996
    Decision Date
    November 26, 1996
    Product Code
    DPS
    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
    DPS Electrocardiograph

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