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510(k) Data Aggregation

    K Number
    K973038
    Device Name
    ADJUSTABLE THERASNORE
    Manufacturer
    DISTAR, INC.
    Date Cleared
    1997-11-12

    (90 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DISTAR, INC.

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

    The Adjustable TheraSnore is a treatment for snoring

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Adjustable Therasnore." This document approves the device for marketing and mentions its indications for use (treatment for snoring).

    However, the document does not contain any information regarding acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, or any other details about performance evaluations. It is solely a regulatory approval document.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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