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510(k) Data Aggregation

    K Number
    K002859
    Device Name
    SSW-STERILE SOLUTION WARMER
    Manufacturer
    KMI KOLSTER METHODS, INC.
    Date Cleared
    2000-11-16

    (64 days)

    Product Code
    LHC
    Regulation Number
    890.5950
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SSW-STERILE SOLUTION WARMER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The K.M.I. SSW Sterile Solution Warmer is intended for the administration of sterile solutions at a controlled temperature drawn from containers using K.M.I. DIK system administration set. The "K" pump is also used in conjunction with this device.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification letter from the FDA to Kolster Methods, Incorporated, regarding their SSW-Sterile Solution Warmer. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt. It is a regulatory approval letter based on a declaration of substantial equivalence, not a detailed study report.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them from the provided text.

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