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510(k) Data Aggregation

    K Number
    K972084
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-07-03

    (29 days)

    Product Code
    FLN
    Regulation Number
    880.2420
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K844556
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Replacement battery for Timeter 41B905FD19G1 KHM2000 Drip Watcher Monitor Insert, 510(k) Number K844556. 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 M212

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available regarding acceptance criteria, device performance testing, or studies conducted on the device.

    The document is a 510(k) clearance letter from the FDA for a "Rechargeable Battery Part Number M212." It primarily focuses on the regulatory determination of substantial equivalence to a predicate device and outlines general compliance requirements.

    Therefore, I cannot populate the requested information.

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