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510(k) Data Aggregation

    K Number
    K981728
    Device Name
    ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1998-06-26

    (42 days)

    Product Code
    BZQ
    Regulation Number
    868.2375
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K862462
    Why did this record match?
    Reference Devices :

    K862462

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

    Replacement battery for Nihon Kohden, Inc LifeScope 6 Portable Patient Monitor, 510(K) Number K862462. This battery is shipped only to customers who request a replacement battery for a particular device or to customers who specifically order this battery and therefore knows the intended use is as a replacement battery.

    Device Description

    Replacement Battery Part Number H134

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a replacement battery, part number H134, for the Nihon Kohden, Inc LifeScope 6 Portable Patient Monitor. It does not contain information related to acceptance criteria, study details, or performance metrics for an AI/device for diagnostic or clinical decision support purposes.

    Therefore, I cannot provide the requested information as it is not present in the provided text.

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