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510(k) Data Aggregation

    K Number
    K012262
    Device Name
    BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC
    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
    Why did this record match?
    Device Name :

    BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC

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

    Replacement battery pack for BAXTER AS40A & AS41 SYRINGE PUMP 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 BAXTER AS40A & AS41 SYRINGE PUMP

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a replacement battery pack, and it does not contain the details required to answer your request.

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