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510(k) Data Aggregation

    K Number
    K981808
    Device Name
    BREATHAID TONGUE SCRAPER
    Manufacturer
    BREATHAID, LLC.
    Date Cleared
    1998-08-11

    (82 days)

    Product Code
    LCN
    Regulation Number
    872.6855
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BREATHAID, LLC.

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies. The document is a 510(k) clearance letter from the FDA for a device called "BreathAid Tongue Scraper." It confirms that the device is substantially equivalent to a predicate device and can be marketed.

    Therefore, I cannot fulfill your request for the detailed information on acceptance criteria and study design as it is not present in the given text.

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