BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    REVERSE-FLOW SYSTEM

    K Number: K834264 · Decision Jan 13, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    10
    Applicant Total
    7
    Review Days
    36

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    Basic Information

    Device Name
    REVERSE-FLOW SYSTEM
    K Number
    K834264
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2560
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Applied Polytechnology, Inc.
    Date Received
    December 8, 1983
    Decision Date
    January 13, 1984
    Product Code
    JTA
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JTA Monitor, Microbial Growth

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