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510(k) Data Aggregation

    K Number
    K973851
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1998-01-05

    (89 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K790373
    Why did this record match?
    Reference Devices :

    K790373

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

    Replacement battery for IVAC Corp. 125053 630 Volumetric Infusion Purnp, Infu-Check #1500, 510(k) Number K790373. 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 #M12/630

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a replacement battery (Alexander Manufacturing Company Rechargeable Battery #M12/630). This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or AI assistance.

    Therefore, I cannot fulfill your request for the requested information based on the provided text. The document is a regulatory approval letter for a medical device and does not detail the technical performance or validation studies of the battery itself.

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