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

    SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM

    K Number: K962492 · Decision Jan 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    72
    Same Product Code
    79
    Applicant Total
    12
    Review Days
    211

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    Basic Information

    Device Name
    SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
    K Number
    K962492
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5965
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nidek Medical Products, Inc.
    Date Received
    June 26, 1996
    Decision Date
    January 23, 1997
    Product Code
    BYE
    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
    BYE Attachment, Breathing, Positive End Expiratory Pressure

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