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

    OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1

    K Number: K100803 · Decision Apr 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    20
    Applicant Total
    29
    Review Days
    31

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    Basic Information

    Device Name
    OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1
    K Number
    K100803
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Keymed, Inc.
    Date Received
    March 22, 2010
    Decision Date
    April 22, 2010
    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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