Spacelabs Medical Model 90481 EEG Module
by Spacelabs Medical, Inc. 510(k)
Active
510(k) K932842
Overview
The Spacelabs Medical Model 90481 EEG Module is a Full-Montage Standard Electroencephalograph, a diagnostic device designed to record electrical activity in the brain. It captures and displays brainwave patterns through electrodes placed on the scalp, enabling clinicians to monitor neurological function, diagnose epilepsy, sleep disorders, and other brain-related conditions. The device supports comprehensive EEG assessments by providing high-resolution recordings and analysis capabilities for clinical interpretation.
This module is intended for use in clinical settings such as hospitals, neurology clinics, and sleep laboratories. Supplied as a reusable medical device, it requires proper calibration and maintenance to ensure accurate and reliable performance. The Model 90481 holds FDA 510(k) clearance (K932842) under the Neurology advisory committee, adhering to regulatory standards for Class II devices (regulation number 882.1400). It is not classified as MRI-safe or MRI-conditional, and storage conditions must comply with manufacturer guidelines to preserve functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK932842 | Date2 Mar 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GWQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Spacelabs Medical, Inc.
Questions
What clinical applications is the Spacelabs Medical Model 90481 EEG Module primarily used for?
The Model 90481 EEG Module is designed for recording and analyzing brainwave patterns to diagnose and monitor neurological conditions. Clinically, it is used to evaluate epilepsy, sleep disorders, and other brain-related conditions by capturing high-resolution EEG data for interpretation by neurologists or sleep specialists in clinical settings like hospitals, neurology clinics, and sleep laboratories.
Is the Spacelabs Medical Model 90481 EEG Module intended for single-use or reusable applications?
The Model 90481 EEG Module is explicitly described as a reusable medical device. It requires proper calibration and maintenance to ensure accurate and reliable performance over multiple uses, as outlined in the manufacturer’s guidelines.
What regulatory pathway was followed for FDA clearance of this EEG Module?
The Spacelabs Medical Model 90481 EEG Module received FDA clearance through a 510(k) submission, classified as substantially equivalent under the Neurology advisory committee. The clearance (K932842) was granted on March 2, 1994, and the device falls under Class II regulatory classification (regulation number 882.1400).
Can this EEG Module be used in an MRI environment, or are there specific safety considerations?
The Model 90481 EEG Module is not classified as MRI-safe or MRI-conditional. If used in proximity to MRI equipment, strict adherence to manufacturer guidelines is required to prevent interference or safety hazards, as the device was not designed for MRI compatibility.
What storage conditions should be followed to maintain the device’s functionality?
While specific storage details are not provided in the data, the manufacturer’s guidelines must be followed to preserve the device’s functionality. This typically includes protecting it from extreme temperatures, humidity, and physical damage, as well as ensuring proper calibration and maintenance routines are adhered to.