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

    LITETOUCH MASK

    K Number: K100285 · Decision Jun 29, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    187
    Registration Numbers
    188
    Same Product Code
    503
    Applicant Total
    5
    Review Days
    148

    Basic Information

    Device Name
    LITETOUCH MASK
    K Number
    K100285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    RESPIRONICS NEW JERSEY, INC.
    Date Received
    February 1, 2010
    Decision Date
    June 29, 2010
    Product Code
    CAF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    CAF Nebulizer (Direct Patient Interface)

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