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

    LOW VOLUME EXTENSION SET

    K Number: K864395 · Decision Dec 16, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    6
    Review Days
    40

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    Basic Information

    Device Name
    LOW VOLUME EXTENSION SET
    K Number
    K864395
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Panamedix, Inc.
    Date Received
    November 6, 1986
    Decision Date
    December 16, 1986
    Product Code
    FPK
    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
    FPK Tubing, Fluid Delivery

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    Other Clearances by Panamedix, Inc.

    K Number Device Name
    K871848 NUTRITION DELIVERY SETS FOR VM 05 AMBULA. PUMP
    K871843 TWO FLUID W/CHECK VALVE
    K871842 TWO FLUID I.V. SETS
    K871841 THREE FLUID I.V. SETS
    K865051 GRASEBY PCAS MODEL NO. 0124-0701, PVS DYTINHR PUMP