BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BREATHE FIT

    K Number: K963326 · Decision Feb 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    173

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    Basic Information

    Device Name
    BREATHE FIT
    K Number
    K963326
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3900
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cambridge Assoc.
    Date Received
    August 23, 1996
    Decision Date
    February 12, 1997
    Product Code
    LWF
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LWF Dilator, Nasal

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