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510(k) Data Aggregation

    K Number
    K013133
    Device Name
    NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
    Manufacturer
    NORDIX, INC.
    Date Cleared
    2001-11-13

    (55 days)

    Product Code
    MOQ,MOZ
    Regulation Number
    878.4820
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORDIX, INC.

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

    Replacement Battery for Baxter Flo-Gard Pump 8000, 8100, 8200 Infusion Pumps inidator. Formps This battery is sold only to customers who request a replacement battery for a particular device or to replace a competitor's Dattery for a particular dovice of to a loss equipment technician knows the intended use is as a replacement battery.

    Device Description

    Nordix Rechargeable Battery Part Number 2116

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Nordix Rechargeable Battery Part Number 2116. This type of document is a regulatory approval, not a scientific study report. It does not contain information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not detail the technical performance studies that might have been conducted for that determination.

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