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510(k) Data Aggregation

    K Number
    K182202
    Device Name
    SLEEPAPP
    Manufacturer
    Comfort Acrylics, Inc.
    Date Cleared
    2019-01-11

    (150 days)

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

    Comfort Acrylics, Inc.

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

    The SLEEPAPPADV is intended for the management of snoring and mild to moderate obstructive sleep apnea in adults 18 years of age and older.

    Device Description

    Not Found

    AI/ML Overview

    This FDA letter for K182202, a 510(k) premarket notification for the SLEEPAPPADV™ device, does not contain information regarding detailed acceptance criteria, specific study designs, or performance metrics. It primarily confirms the device's substantial equivalence to a predicate device and outlines general regulatory obligations.

    Therefore, I cannot provide the requested information, including the table of acceptance criteria and device performance, sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, ground truth types, or training set details. This information is typically found in the 510(k) summary or the full submission, which is not provided in the given text.

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