BEUDAMED
    Product Code: LZF FDA class 2 21 CFR 880.5725

    Pump, Infusion, Analytical Sampling

    General Hospital

    The Analytical Sampling Infusion Pump (product code LZF) is a precision pump device used to deliver fluids at controlled rates for analytical sampling purposes in clinical or laboratory settings, such as in automated clinical analyzers or continuous monitoring systems. Regulated under 21 CFR 880.5725 and classified as a Class 2 device, it requires a 510(k) premarket notification and falls under the General Hospital specialty with review by the Chemistry (CH) panel. It is not an implant and is not life-sustaining.

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    510(k)s
    7
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    5
    Years Active
    31

    Basic Information

    Product Code
    LZF
    Device Class
    FDA class 2
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K192785 OptiScanner® 5000 Glucose Monitoring System
    K162042 OptiScanner 5000 Glucose Monitoring System
    K011238 RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM
    K951739 PUMP/BLOOD CHEMISTRY MONITOR
    K922997 VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD.
    K920438 VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM
    K882830 INFUSION PUMP

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.