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510(k) Data Aggregation

    K Number
    K972780
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-10-20

    (87 days)

    Product Code
    MRZ
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K821661
    Why did this record match?
    Reference Devices :

    K821661

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

    Replacement battery for Ross Laboratories, Div. of Abbott Labs Flexiflo II Infusion Pump, 510(k) Number K821661. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

    Device Description

    Rechargeable Battery Part Number GL625

    AI/ML Overview

    This document is solely a 510(k) clearance letter for a replacement battery, indicating its substantial equivalence to a previously marketed device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details that would allow for a discussion of AI performance or comparative effectiveness.

    Therefore, I cannot fulfill your request for information on acceptance criteria and a study proving device performance based on the provided text.

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