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

    MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.

    K Number: K871712 · Decision Jan 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    11
    Applicant Total
    8
    Review Days
    255

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    Basic Information

    Device Name
    MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.
    K Number
    K871712
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Machida America, Inc.
    Date Received
    May 4, 1987
    Decision Date
    January 14, 1988
    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 Machida America, Inc.

    K Number Device Name
    K854581 MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50
    K844834 MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1
    K841087 FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000
    K821182 MODEL ENT-4L-FLEXIBLE NASOPHARYNGO-
    K821181 FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE #
    K812734 MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P
    K811943 MACHIDA NASOPHARYNGO-LARYNGOSCOPE