Compumedics Somte Psg Recording System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K072201 FDA 510(k)
- FDA Product Code
- MNR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.2375 FDA 510(k)
- Regulation Number
- 868.2375 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Somté PSG Recording System is a portable polysomnography (PSG) device classified as a Ventilatory Effort Recorder. It is designed for comprehensive Type I PSG recordings, enabling both attended in-lab and unattended ambulatory sleep studies through wireless monitoring and flexible data acquisition. The system captures multi-channel physiological data to assess respiratory and cardiac functions.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings, including hospitals and home environments. It adheres to FDA 510K and MDD regulatory standards, with a classification as a Class II device. The system requires appropriate training for operation and maintenance, and its use is governed by the specified regulatory authorisations. No MRI safety information or sterility details are provided in the specifications.
Frequently asked questions
What types of sleep studies can the Somté PSG Recording System perform, and where can it be used?
The Somté PSG Recording System is designed for comprehensive Type I polysomnography (PSG) recordings, which assess both respiratory and cardiac functions. It supports both attended in-lab studies and unattended ambulatory sleep studies, making it versatile for clinical settings like hospitals as well as home environments. The wireless monitoring and flexible data acquisition capabilities enable seamless use across different environments while maintaining comprehensive diagnostic accuracy.
Is the Somté PSG Recording System single-use or reusable, and what does that mean for maintenance?
The Somté PSG Recording System is reusable, meaning it is intended for repeated use in clinical settings after proper cleaning, maintenance, and calibration. Since it is classified as a reusable medical instrument, it requires appropriate training for operation and maintenance to ensure accuracy, reliability, and compliance with regulatory standards. The manufacturer emphasizes adherence to best practices for longevity and performance.
What regulatory pathways does the Somté PSG Recording System follow, and how does that affect its use?
The Somté PSG Recording System is authorized under FDA 510K and MDD (Medical Device Directive) regulatory pathways, classifying it as a Class II device. This means it has undergone evaluation to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and performance standards. Its use is governed by these regulatory authorizations, and clinical staff must ensure compliance with applicable guidelines and training requirements for proper operation.
Does the Somté PSG Recording System come with specific models or configurations, and how do I determine the right one for my needs?
The Somté PSG Recording System is associated with multiple FEI (Facility Establishment Identifier) and registration numbers, indicating it may be available in various configurations or software versions tailored for different clinical workflows. While the exact models aren’t detailed in the specifications, the system’s flexibility for in-lab and ambulatory studies suggests compatibility with a range of settings. Consulting the manufacturer or reviewing the technical documentation will help identify the most suitable version for your specific diagnostic requirements.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Somté PSG (Compumedics) | NEUROSPEC, Somté - Compumedics, Somté (Compumedics) | NEUROSPEC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K072201 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Compumedics Limited
Sources (2)
- FDA 510(k) K072201 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026