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510(k) Data Aggregation

    K Number
    K012266
    Device Name
    SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2
    Manufacturer
    NATIONAL CUSTOM ENT., INC.
    Date Cleared
    2001-09-12

    (56 days)

    Product Code
    MRZ
    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

    Replacement battery pack for SHERWOOD 224, 324 FEEDING PUMP & SHERWOOD K524 INTRI-FLUSH This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above

    Device Description

    Replacement battery pack for SHERWOOD 224, 324 FEEDING PUMP & SHERWOOD K524 INTRI-FLUSH

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for a replacement battery pack. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot generate the requested information based on the provided text.

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