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510(k) Data Aggregation

    K Number
    K972089
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-07-03

    (29 days)

    Product Code
    MRZ
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K945964
    Why did this record match?
    Reference Devices :

    K945964

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

    Replacement battery for Sherwood Medical Systems 10489 Kangaroo Feeding Pump Models 524, 224, 324, 510(k) Number K945964.

    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 MS06224

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a replacement battery, and it does not contain the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device's performance evaluation. The document focuses on regulatory approval rather than technical performance studies.

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