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

    TRANSONIC SYRINGE WARMER, MODEL SYR-1000

    K Number: K022963 · Decision Dec 4, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    17
    Applicant Total
    16
    Review Days
    89

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    Basic Information

    Device Name
    TRANSONIC SYRINGE WARMER, MODEL SYR-1000
    K Number
    K022963
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Transonic Systems, Inc.
    Date Received
    September 6, 2002
    Decision Date
    December 4, 2002
    Product Code
    MQS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQS System, Hemodialysis, Access Recirculation Monitoring

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