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510(k) Data Aggregation

    K Number
    K972086
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-08-12

    (69 days)

    Product Code
    BZK
    Regulation Number
    868.1850
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K862687
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K862687

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Replacement battery for OHMEDA (Ohio Medical Products) 690-1000-311 Volume Monitor 5400, 5410, 5420, 6800, 510(k) Number K862687. 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 MS311

    AI/ML Overview

    I am sorry, but after reviewing the provided documents, I could not find information about specific acceptance criteria for a device, nor details of a study proving a device meets such criteria. The documents are a letter from the FDA regarding a 510(k) clearance for a replacement battery (K972086) and its indications for use. They do not contain technical specifications, performance metrics, or study designs and results.

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