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510(k) Data Aggregation

    K Number
    K972746
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-10-21

    (90 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K810154
    Why did this record match?
    Device Name :

    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100

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

    Replacement battery for Physio-Control 800285-01 Life Pak 6 & 7 Monitor, 510(k) Number K810154. 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 for Physio-Control 800285-01 Life Pak 6 & 7 Monitor

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a replacement battery (LP6/100) for medical devices.

    This document does not contain any information about acceptance criteria or a study proving the device meets those criteria for the battery. It is a regulatory approval letter stating that the device is substantially equivalent to a predicate device.

    Therefore, I cannot provide the requested information based on the input text.

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