Sleep Analyzing Computer

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K862527 ↗

FDA Product Code

OLZ

Device Class

Class II

Regulation

21 CFR Part 882.1400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Sac 747 and Sac 847 (Sleep Analyzing Computers)

  Class II

  FDA 510(k) K890513 Active Cleared 28 Apr 1989

• The Wonder Box

  Class II

  FDA 510(k) K901797 Active Cleared 7 Feb 1991

• Myotone EMG Monitor

  Class II

  FDA 510(k) K772005 Active Cleared 23 Nov 1977

• Model 8 EEG Preamplifier

  Class II

  FDA 510(k) K863124 Active Cleared 18 Nov 1986

• Perci

  Class I

  FDA 510(k) K780838 Active Cleared 17 Jul 1978

• What types of sleep events does the Sleep Analyzing Computer detect and classify, and how does it help clinicians?

  The Sleep Analyzing Computer is designed to automatically detect and classify key sleep events such as arousals, sleep stages, and EEG abnormalities. By processing polysomnography data—including electroencephalograph (EEG) and other physiological signals—it provides objective, standardized analysis to aid clinicians in assessing sleep patterns and diagnosing sleep disorders more efficiently.

• Is the Sleep Analyzing Computer a standalone software, or does it require integration with other systems to function?

  The Sleep Analyzing Computer is supplied as software intended to interface with polysomnography systems in clinical sleep laboratories. While it operates as part of an existing polysomnography workflow, its functionality depends on compatibility with the laboratory’s recording systems and maintenance protocols, which may influence whether it is used repeatedly or per session.

• How is the Sleep Analyzing Computer regulated, and what does its FDA clearance status imply for users?

  The Sleep Analyzing Computer holds FDA 510(k) clearance (K862527) under the Traditional clearance type, classified as a Class II device. This means it has been determined to be substantially equivalent to a legally marketed device and adheres to FDA regulations, including 882.1400. Users can rely on this clearance as evidence of its compliance with U.S. regulatory standards for automatic event detection software in polysomnography.

• Can the Sleep Analyzing Computer be reused across multiple patient sessions, or is it intended for single-use?

  While the software itself is technically reusable, its practical use depends on the polysomnography system’s compatibility and maintenance protocols. The manufacturer does not explicitly state single-use, but its design aligns with clinical workflows where it processes data per recording session, often requiring validation or recalibration for repeated use.

• What medical specialty does the Sleep Analyzing Computer primarily support, and why is this relevant for clinicians?

  The Sleep Analyzing Computer is classified under the medical specialty of Neurology, as indicated by its advisory committee (NE) and OpenFDA categorization. This reflects its role in analyzing EEG data and diagnosing sleep-related disorders, making it particularly relevant for neurologists, sleep specialists, and other clinicians focused on neurological or sleep medicine.