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510(k) Data Aggregation

    K Number
    K980086
    Device Name
    HEAT STACK
    Manufacturer
    MEDICAL SOLUTIONS, INC.
    Date Cleared
    1998-03-10

    (60 days)

    Product Code
    LGZ
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medical Solutions Heat Stack warming cabinet is designed to store and warm I.V. fluid bags/bottles, irrigation solution bags/bottles, blankets, towels, ec. prior to their use, using forced heated air.

    Warning: The facility should contact the manufacturer of the products to be placed inside the warming cabinet and obtain guidelines for exposing their product to temperatures other than those stated on the bags and bottles.

    Device Description

    The Medical Solutions Heat Stack warming cabinet is designed to store and warm I.V. fluid bags/bottles, irrigation solution bags/bottles, blankets, towels, ec. prior to their use, using forced heated air.

    AI/ML Overview

    This document is a letter from the FDA to a medical device manufacturer, confirming the substantial equivalence of a device. It does not contain any information about acceptance criteria or a study proving device performance.

    Therefore, I cannot provide the requested information.

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