EEG-Now
510(k) K180524
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK180524 | Date18 May 2018 | 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- Withdrawn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
- GXY
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1320
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The EEG-Now Electrode Array is a Cutaneous Electrode designed for electroencephalography (EEG) recordings. It functions as a reusable electrode array system for capturing brain wave activity, enabling real-time monitoring and interpretation of neural signals at the point of care. This device facilitates rapid application and removal, supporting continuous 24/7 EEG assessment for diagnostic purposes. Its classification aligns with Electrode, Cutaneous under FDA product code GXY, ensuring compliance with Class II regulatory standards.
The device is intended for use in clinical settings where immediate EEG data is required, such as emergency departments or intensive care units. Supplied as a reusable system, it requires proper cleaning and maintenance between uses to ensure accuracy and sterility. The EEG-Now has received FDA 510(k) clearance under the Traditional review pathway, declared substantially equivalent to a predicate device. No additional sterility or single-use specifications are noted in the regulatory submission.
Questions
AI-generated answers, 1 Oct 2026
What is the EEG-Now Electrode Array used for?
The EEG-Now Electrode Array is designed for electroencephalography (EEG) recordings to capture brain wave activity. It supports real-time monitoring and interpretation of neural signals, making it ideal for clinical environments like emergency departments or intensive care units where immediate EEG data is critical for diagnosis.
Is the EEG-Now Electrode Array reusable or single-use?
The EEG-Now Electrode Array is a reusable system. To maintain accuracy and sterility, it requires proper cleaning and maintenance between uses. This design allows for repeated use in clinical settings, provided it is handled according to manufacturer guidelines.
How does the EEG-Now Electrode Array ensure compliance with regulatory standards?
The EEG-Now Electrode Array is classified under the FDA product code GXY as a Class II device, specifically as a cutaneous electrode. It has received FDA 510(k) clearance through the Traditional review pathway, declared substantially equivalent to a predicate device. This ensures it meets the necessary regulatory requirements for use in clinical settings.
What are the key features that make the EEG-Now Electrode Array suitable for point-of-care use?
The EEG-Now Electrode Array is designed for rapid application and removal, enabling continuous 24/7 EEG assessment without delay. This feature is particularly valuable in fast-paced environments like emergency departments or intensive care units, where quick and reliable neural signal monitoring is essential for timely clinical decisions.
What maintenance is required to keep the EEG-Now Electrode Array functional?
Since the EEG-Now Electrode Array is reusable, it requires proper cleaning and maintenance between uses to ensure its accuracy and sterility. The manufacturer provides guidelines for handling and care, which must be followed to maintain optimal performance and compliance with clinical standards.