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

    AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor

    K Number: K181472 · Decision Apr 23, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    56
    Applicant Total
    5
    Review Days
    323

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    Basic Information

    Device Name
    AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
    K Number
    K181472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Sterilization Products (Asp)
    Date Received
    June 4, 2018
    Decision Date
    April 23, 2019
    Product Code
    FEB
    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
    FEB Accessories, Cleaning, For Endoscope

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