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510(k) Data Aggregation

    K Number
    K971234
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-05-27

    (55 days)

    Product Code
    MRZ
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K840263
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Replacement battery for Abbott Medical Electronics 190706 Life Care Pump 4,5 (micro infusion pump), 510(k) Number K840263.

    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 GL825

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA to Alexander Manufacturing Company for a rechargeable battery (Part Number GL825). This document primarily establishes the FDA's finding of substantial equivalence for the device to a predicate device marketed before May 28, 1976.

    As such, this document does not contain the acceptance criteria or the study details to prove the device meets acceptance criteria for an AI/ML medical device. It is a regulatory clearance letter for a standard medical device (a replacement battery), not an AI/ML product.

    Therefore, I cannot provide the requested information from the given text.

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