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

    MANZI CLEANER SYSTEM

    K Number: K043314 · Decision Jun 20, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    11
    Applicant Total
    3
    Review Days
    201

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    Basic Information

    Device Name
    MANZI CLEANER SYSTEM
    K Number
    K043314
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Langford IC Systems, Inc.
    Date Received
    December 1, 2004
    Decision Date
    June 20, 2005
    Product Code
    NVE
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NVE Washer, Cleaner, Automated, Endoscope

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    Other Clearances by Langford IC Systems, Inc.

    K Number Device Name
    K101158 LIC INSTRUMENT PROCESSING SYSTEM
    K060458 MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR