LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K013587
    Device Name
    BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS
    Manufacturer
    BABIES BEST, INC.
    Date Cleared
    2002-05-14

    (196 days)

    Product Code
    KKO
    Regulation Number
    872.5550
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For teething human infants to chew on. To soothe gums when teething.

    Device Description

    fluid-filled teething ring

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a "Fluid-Filled Teething Ring." It confirms the substantial equivalence of the device to legally marketed predicate devices and outlines regulatory requirements.

    However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the text provided. This FDA letter is a regulatory approval, not a scientific study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1