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510(k) Data Aggregation

    K Number
    K971107
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-06-05

    (71 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K951281,K942018,K840110
    Why did this record match?
    Reference Devices :

    K951281, K942018, K840110

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

    Replacement battery for R & D Battery part number(s) 5025 (K#K951281 AND K942018).

    This battery is a replacement battery for Laerdal Medical Corp. 79-12-05 7050 Series Suction Cup, 510(k) 14 Number K840110.

    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 STR5

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a replacement battery. It confirms substantial equivalence but does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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