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

    PERCUPUMP II

    K Number: K932055 · Decision Mar 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    56
    Review Days
    692

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    Basic Information

    Device Name
    PERCUPUMP II
    K Number
    K932055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    E-Z-Em, Inc.
    Date Received
    April 28, 1993
    Decision Date
    March 21, 1995
    Product Code
    FIH
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FIH Pump, Infusion Or Syringe, Extra-Luminal

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