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

    KEISEI

    K Number: K950613 · Decision Feb 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    56
    Applicant Total
    2
    Review Days
    369

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    Basic Information

    Device Name
    KEISEI
    K Number
    K950613
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5110
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Keisei (Usa) Co., Ltd.
    Date Received
    February 10, 1995
    Decision Date
    February 14, 1996
    Product Code
    CAE
    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
    CAE Airway, Oropharyngeal, Anesthesiology

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    Other Clearances by Keisei (Usa) Co., Ltd.

    K Number Device Name
    K925651 LIFE ISLAND 21