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510(k) Data Aggregation

    K Number
    K972787
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-10-17

    (84 days)

    Product Code
    DRT
    Regulation Number
    870.2300
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K772056
    Why did this record match?
    Device Name :

    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P

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

    Replacement battery for Datascope 0146-00-0019 Models 870 & 871 Physiological Monitors, 510(k) Number K76080 & K772056.

    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 M850-P

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a replacement battery, and it does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results.

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