The Modular Headstage-36 is a clinical headstage that connects to one of several modular electrode interfaces to connect electrodes from various manufacturers to the ATLAS Neurophysiology…
The Modular Headstage-36 is a clinical headstage that connects to one of several modular electrode interfaces to connect electrodes from various manufacturers to the ATLAS Neurophysiology System. The Modular Headstage-36 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Modular Headstage-36 | Listed by | Neuralynx, Inc., United States |
| FDA product code | OMC |
| Device type | Reduced- Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Manufacturer |
| 510(k) | K110967 |
| Record published | 2021-11-05 |
| Record revised | 2023-07-12 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.