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

    PHARMACOKINETICS SOFTWARE SYSTEM (PPS)

    K Number: K864121 · Decision Dec 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    54
    Applicant Total
    1
    Review Days
    50

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    Basic Information

    Device Name
    PHARMACOKINETICS SOFTWARE SYSTEM (PPS)
    K Number
    K864121
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1890
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Pharmatrol, Inc.
    Date Received
    October 21, 1986
    Decision Date
    December 10, 1986
    Product Code
    NDC
    Advisory Committee
    Anesthesiology
    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
    NDC Calculator, Drug Dose

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