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510(k) Data Aggregation

    K Number
    K971604
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-07-28

    (88 days)

    Product Code
    DSH
    Regulation Number
    870.2800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K884911,K850011,K760676,K790757
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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 LP5-FP

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a replacement battery (LP5-FP). It does not contain information about acceptance criteria or a study demonstrating device performance.

    Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study that proves the device meets those criteria.

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