The ATLAS HD Headbox is a clinical headbox that allows electrode connections ending in an MDR-68 connector to interface with the ATLAS Neurophysiology System. The ATLAS HD Headbox allows…
The ATLAS HD Headbox is a clinical headbox that allows electrode connections ending in an MDR-68 connector to interface with the ATLAS Neurophysiology System. The ATLAS HD Headbox allows two MDR-68 connectors to be tied in parallel and a switch to disable active driven ground supplied by the ATLAS Neurophysiology system.
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 Atlas HD Headbox | 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 2) |
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.