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510(k) Data Aggregation

    K Number
    K033402
    Device Name
    PORTABLE SLEEP DATA RECORDER (PSDR)
    Manufacturer
    PRO-TECH SERVICES, INC.
    Date Cleared
    2004-06-30

    (250 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PORTABLE SLEEP DATA RECORDER (PSDR)

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

    The PSDR system is a physiological recorder intended to display and to record for later playback of thoracic and abdominal respiratory effort, airflow, oxygen saturation, pulse rate, and a 0-1 volt DC signal (such as CPAP pressure) on the auxiliary input. The PSDR is designed to be used in a supervised (hospital/institutional) or unsupervised (home) environment.

    Device Description

    Portable Sleep Data Recorder

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a "Portable Sleep Data Recorder." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. However, the document does NOT contain any information about acceptance criteria, device performance results, sample sizes for testing or training, expert qualifications, ground truth establishment methods, or whether MRMC or standalone studies were conducted.

    Therefore, I cannot provide the requested table and study details. The letter is a regulatory approval document, not a technical performance report.

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