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

    FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01

    K Number: K003582 · Decision Dec 5, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    2
    Review Days
    15

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    Basic Information

    Device Name
    FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01
    K Number
    K003582
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fluidsense Corp.
    Date Received
    November 20, 2000
    Decision Date
    December 5, 2000
    Product Code
    FRN
    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
    FRN Pump, Infusion

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    Other Clearances by Fluidsense Corp.

    K Number Device Name
    K982170 FLUIDSENSE FLUID DELIVERY SYSTEM