LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K110615
    Device Name
    WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
    Manufacturer
    BEBE TOYS MANUFACTORY LTD.
    Date Cleared
    2011-12-02

    (274 days)

    Product Code
    KKO
    Regulation Number
    872.5550
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEBE TOYS MANUFACTORY LTD.

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

    The Water Filled Teether is used for the temporary relief of pain and discomfort in infants and toddlers caused by teething.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a Water Filled Teether. It is a regulatory approval document, not a study report. Therefore, it does not contain the information requested about acceptance criteria, device performance, study details, or ground truth establishment.

    The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for this type of device based on existing standards, rather than new performance studies with specific statistical outcomes.

    Therefore, I cannot extract the requested information from the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1