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510(k) Data Aggregation

    K Number
    K971099
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-06-05

    (71 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K831852
    Why did this record match?
    Reference Devices :

    K831852

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

    Replacement battery for Corometrics Medical 5169, 41B035BA01501 ECG Monitor 115, 6153A, 510(k) Number K831852. 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

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for a replacement battery (Part Number MS5169) for Corometrics Medical ECG Monitors. It is a regulatory document and does not contain any information about acceptance criteria for a device's performance, nor does it describe any studies proving a device meets such criteria.

    Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and a study to prove device performance based on the provided text. The document's purpose is to state that the FDA has determined the replacement battery to be "substantially equivalent" to legally marketed predicate devices.

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