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

    SMART-WELL EZTEST INCUBATOR

    K Number: K091950 · Decision Jan 15, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    205
    Applicant Total
    4
    Review Days
    198

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    Basic Information

    Device Name
    SMART-WELL EZTEST INCUBATOR
    K Number
    K091950
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sgm Biotech, Inc.
    Date Received
    July 1, 2009
    Decision Date
    January 15, 2010
    Product Code
    FRC
    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
    FRC Indicator, Biological Sterilization Process

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    Other Clearances by Sgm Biotech, Inc.

    K Number Device Name
    K093794 SMART-READ EZTEST-STEAM SCBI AND TEST PACK
    K963841 EZTEST
    K930682 EZTEST-STEAM