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

    AMT Enteral Transition Adapters

    K Number: K150034 · Decision Jun 9, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    8
    Applicant Total
    25
    Review Days
    151

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    Basic Information

    Device Name
    AMT Enteral Transition Adapters
    K Number
    K150034
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Applied Medical Technology, Inc.
    Date Received
    January 9, 2015
    Decision Date
    June 9, 2015
    Product Code
    PIO
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PIO Enteral Specific Transition Connectors

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