Model 1210, Medium E-Net
510(k) K960873
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK960873 | Date26 Apr 1996 | 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- Withdrawn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 Model 1210, Medium E-Net is a headpiece designed for EEG monitoring. It fits patients with a head circumference of 48-54 cm and functions as part of the Hydro Dot NeuroMonitoring System. The device locates EEG electrodes according to the 10-20 International System and conducts electrical signals from the skin to EEG equipment.
It is used in clinical settings by healthcare professionals. The device is supplied as a non-sterile, reusable component. No information regarding MRI safety, storage conditions, or additional authorizations beyond the FDA 510(k) clearance (K960873) is provided in the data.
Other devices from Physiometrix, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Model 1210 Medium E-Net used for?
The Model 1210 Medium E-Net is a headpiece designed to position and secure EEG electrodes according to the 10-20 International System, enabling the transmission of electrical signals from the scalp to EEG monitoring equipment in clinical settings.
Is the Model 1210 Medium E-Net sterile or non-sterile, and is it intended for single use or reuse?
The Model 1210 Medium E-Net is supplied as a non-sterile component and is designed for reuse, meaning it can be cleaned and used multiple times on different patients following appropriate infection control procedures.
What patient head size range does the Model 1210 Medium E-Net accommodate?
The Model 1210 Medium E-Net is specifically designed to fit patients with a head circumference ranging from 48 cm to 54 cm, ensuring proper electrode placement for accurate EEG signal acquisition.