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510(k) Data Aggregation

    K Number
    K970786
    Device Name
    ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7)
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-05-27

    (84 days)

    Product Code
    MRZ
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K833983
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use in Pancrete, Inc. U-100 Insulin Infusion Pump (K#833983) --- 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

    M7 Replacement Battery

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to Alexander Manufacturing Company for their Rechargeable Battery (Model M7). It confirms substantial equivalence but does not contain any information regarding acceptance criteria or a study proving device performance.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence to a predicate device, not on specific performance studies or acceptance criteria for the battery itself.

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