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

    ORL Video NasoPharyngo-Larngoscope

    K Number: K150248 · Decision Jul 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    170

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    Basic Information

    Device Name
    ORL Video NasoPharyngo-Larngoscope
    K Number
    K150248
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4760
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jedmed Instrument Company
    Date Received
    February 3, 2015
    Decision Date
    July 23, 2015
    Product Code
    EQN
    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
    EQN Laryngoscope, Nasopharyngoscope

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