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510(k) Data Aggregation

    K Number
    K971235
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1997-06-05

    (64 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K863784
    Why did this record match?
    Device Name :

    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W

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

    Replacement battery for Nellcor, Inc. 0810-0103 N-200 Pulse Oximeter with Factory Replacement Block, 510(k) Number K863784.

    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 Nellcor, Inc. 0810-0103 N-200 Pulse Oximeter with Factory Replacement Block, 510(k) Number K863784.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a replacement battery, and it primarily focuses on the regulatory approval and substantial equivalence determination for this specific device. It does not include any details about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

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