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

    MPC-80 TRANSDUCER

    K Number: K925978 · Decision Jan 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    34
    Applicant Total
    7
    Review Days
    415

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    Basic Information

    Device Name
    MPC-80 TRANSDUCER
    K Number
    K925978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Molded Products, Inc.
    Date Received
    November 25, 1992
    Decision Date
    January 14, 1994
    Product Code
    FIB
    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
    FIB Protector, Transducer, Dialysis

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    Other Clearances by Molded Products, Inc.

    K Number Device Name
    K022068 TUBING, DIALYSATE (AND CONNECTOR)
    K010366 DISPOSABLE STORAGE CAP
    K010712 DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
    K003712 MODIFICATION TO MALE TO MALE LUER ADAPTER
    K925930 MPC-150 MALE TO MALE LUER ADAPTER
    K925927 MPC-1000 INJECTION CAP/PLUG