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510(k) Data Aggregation

    K Number
    K971237
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108
    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
    K811238
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Replacement battery for IVAC Corp. 0810-0008 560/560 Plus/565/570 Models Variable Pressure Pump, 510(k) Number K811238.

    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 GL8108

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding a rechargeable battery (Part Number GL8108). This document is a regulatory communication and does not contain information about acceptance criteria for device performance, clinical study details, or ground truth establishment.

    Therefore, I cannot provide the requested information. The document focuses on the substantial equivalence of the battery to a predicate device for its intended use as a replacement battery for specific IVAC Corp. pump models.

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