Michele Sleep Scoring Systems
510(k) K112102
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112102 | Date20 Dec 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MNR
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.2375
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Michele Sleep Scoring Systems is a computer-based software solution classified as a Ventilatory Effort Recorder. It is designed to process and analyze digital data from sleep monitoring devices, enabling automatic and manual scoring of sleep parameters. The system supports the evaluation of sleep and respiratory-related disorders by facilitating data display, retrieval, summarization, and report generation. Its functionality includes networking capabilities to integrate with other diagnostic tools.
The device is supplied as a software program intended for use on compatible computing platforms. It is not classified as single-use or reusable but requires installation on a computer system. The system operates under FDA clearance via the 510(k) pathway (K112102) and adheres to ventilatory monitoring standards. No sterility or MRI safety information is provided, as it is a software-based solution. Use is restricted to clinical settings by trained professionals for diagnostic assistance in sleep disorders.
Questions
AI-generated answers, 1 Oct 2026
What is the Michele Sleep Scoring Systems used for?
The Michele Sleep Scoring Systems is a computer-based software solution designed as a Ventilatory Effort Recorder. It processes digital data from sleep monitoring devices to automatically and manually score sleep parameters, such as respiratory events and sleep stages. Clinicians use it to evaluate sleep-related disorders, including obstructive sleep apnea and other ventilatory abnormalities, by displaying, summarizing, and generating reports from the data. The system integrates with other diagnostic tools via networking, supporting comprehensive diagnostic workflows in clinical settings.
How is the Michele Sleep Scoring Systems supplied and installed?
The Michele Sleep Scoring Systems is supplied as a software program that must be installed on compatible computing platforms. Unlike hardware devices, it is not single-use or reusable—it requires permanent installation on a computer system to function. The software is intended exclusively for clinical use by trained professionals and does not involve physical hardware components or sterilization processes.
Is the Michele Sleep Scoring Systems sterile or MRI-safe?
The Michele Sleep Scoring Systems is a software-based solution, so it does not require sterility or have MRI safety considerations. Since it operates entirely on a computer system, there are no physical components that would necessitate sterilization or compatibility with MRI environments. Always ensure the host computer meets the system’s technical requirements for safe and accurate operation.
Can the Michele Sleep Scoring Systems be used outside clinical settings?
No, the Michele Sleep Scoring Systems is explicitly designed for use in clinical settings only. Its functionality, including data analysis, scoring, and reporting, is intended to assist trained professionals in diagnosing sleep and respiratory disorders. Use outside a regulated clinical environment may compromise accuracy, compliance, or patient safety, as the software lacks safeguards for non-professional or non-diagnostic applications.
What regulatory pathway does the Michele Sleep Scoring Systems follow?
The Michele Sleep Scoring Systems has received FDA clearance through the 510(k) pathway, specifically under the clearance number K112102. This classification confirms that the device is deemed substantially equivalent to a legally marketed predicate device and adheres to ventilatory monitoring standards. The system is also categorized under the medical specialty of Anesthesiology, reflecting its role in supporting diagnostic evaluations related to respiratory and sleep disorders.