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510(k) Data Aggregation

    K Number
    K971828
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-08-12

    (88 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K822909
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Replacement battery for Nellcor, Inc. 0810-0115 N-100 Pulse Oximeter, 510(k) Number K822909.

    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

    Replacement Battery Part Number GL0810-0115

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Alexander Manufacturing Company regarding a replacement battery. This document primarily focuses on regulatory approval and does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot extract the requested information to fill in the table or answer the questions related to device performance studies. The document only states that the device is "substantially equivalent" to legally marketed predicate devices.

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