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

    VOLUMERIC CONTROLLER

    K Number: K823404 · Decision Dec 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    59
    Applicant Total
    39
    Review Days
    37

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    VOLUMERIC CONTROLLER
    K Number
    K823404
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Quest Medical, Inc.
    Date Received
    November 15, 1982
    Decision Date
    December 22, 1982
    Product Code
    LDR
    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
    LDR Controller, Infusion, Intravascular, Electronic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LDR), ordered by most recent decision date.

    DEKA Infusion System, DEKA Administration Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEKA Infusion System, DEKA Administration Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Volumetric Infusion Controller

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PACER MODEL 100 INFUSION CONTROLLER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Quest Medical, Inc.

    K Number Device Name
    K241058 Lyka® PORT Needle Free Access Device (4170Y)
    K213846 Q2 Blood Administration Sets
    K213588 Q2 IV Administration Sets
    K202672 Precision Delivery Infusion Set
    K201984 MPS 3 ND Myocardial Protection System
    K200438 MPS 3 Myocardial Protection System
    K182442 MiniGuard Arterial Safety Valve
    K173716 MPS2 Myocardial Protection System Console
    K162804 Q2 Low Pressure Power Injection Extension Set
    K162304 Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets
    Search all 39 clearances from Quest Medical, Inc. →