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

    AquaShield system CO2, AquaShield system-PENTAX

    K Number: K153362 · Decision Dec 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    20
    Applicant Total
    94
    Review Days
    26

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    Basic Information

    Device Name
    AquaShield system CO2, AquaShield system-PENTAX
    K Number
    K153362
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    United States Endoscopy Group, Inc.
    Date Received
    November 20, 2015
    Decision Date
    December 16, 2015
    Product Code
    FEQ
    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
    FEQ Pump, Air, Non-Manual, For Endoscope

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