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

    BERMAN AIRWAY

    K Number: K936134 · Decision Jan 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    56
    Applicant Total
    22
    Review Days
    36

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    Basic Information

    Device Name
    BERMAN AIRWAY
    K Number
    K936134
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5110
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smiths Industries Medical Systems, Inc.
    Date Received
    December 23, 1993
    Decision Date
    January 28, 1994
    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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