BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM

    K Number: K030611 · Decision Mar 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    160
    Applicant Total
    1
    Review Days
    26

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    Basic Information

    Device Name
    MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM
    K Number
    K030611
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nellcor Puritan Bennett (Melville) , Ltd.
    Date Received
    February 26, 2003
    Decision Date
    March 24, 2003
    Product Code
    MNR
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MNR Ventilatory Effort Recorder

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