BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers

    K Number: K170304 · Decision Mar 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    1
    Review Days
    395

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    Basic Information

    Device Name
    Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers
    K Number
    K170304
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Astell Scientific Limited
    Date Received
    January 31, 2017
    Decision Date
    March 2, 2018
    Product Code
    FLE
    Advisory Committee
    General Hospital
    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
    FLE Sterilizer, Steam

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