Q21
The Q21 is a 19 channel EEG amplifier with a low noise floor of 0.25 microvolts peak to peak from 0.1 to 10.0Hz, meaning that you can record brain wave data without worrying about noise…
The Q21 is a 19 channel EEG amplifier with a low noise floor of 0.25 microvolts peak to peak from 0.1 to 10.0Hz, meaning that you can record brain wave data without worrying about noise contamination. On top of our low-noise design, the Q21 is a non-multiplexed, multi-channel readout amp, minimizing slew for the most accurate whole brain imaging, and giving you the exact readout of your EEG recordings, with no loss of data or smoothing.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Neurofield, Inc., United States |
|---|---|
| FDA product code | OLT |
| Device type | Non-Normalizing Quantitative Electroencephalograph Software |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K221959 |
| Record published | 2025-06-02 |
| Record revised | 2026-05-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 169 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Non-Normalizing Quantitative Electroencephalograph Software | Nihon Kohden America, Inc. | 28 |
| Non-Normalizing Quantitative Electroencephalograph Software | Nihon Kohden Corp. | 18 |
| Neurofax | Nihon Kohden America, Inc. | 14 |
| Stratus EEG | Kvikna Medical ehf | 4 |
| Nihon Kohden, EEG-1200A Series Neurofax | Nihon Kohden Corp. | 4 |
| Component Neuromonitoring System | Moberg Research, Inc. | 3 |
| Easy III | Cadwell Industries, Inc. | 3 |
| GCX | Nihon Kohden America, Inc. | 3 |
| Neurofax | Nihon Kohden Corp. | 2 |
| Non-Normalizing Quantitative Electroencephalograph Software | GE Healthcare Finland OY | 2 |
| E-Eegx | GE Healthcare Finland OY | 1 |
| Lifelines iEEG Portable Yoga Tablet No Video | Kvikna Medical ehf | 1 |
Showing 12 of 38. All products under Non-Normalizing Quantitative Electroencephalograph Software
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.