Q21
- Primary DI
- 00860410000379
- Brand
- Q21
- Company
- NEUROFIELD, INC.
- Model
- 169
- Device description
- 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.
- Published
- 2025-06-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| OLT | Non-Normalizing Quantitative Electroencephalograph Software |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | Neurology | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K221959 | 000 | Q21 | Neurofield, Inc. | 2023-08-31 | GWQ |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00860410000379 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00860410000379 | 00860410000379 | 860410000379 | 0860410000379 |
GMDN Terms
| Term | Definition |
|---|
| Multiple physiological signal amplifier | An electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy. |
Regulatory Flags
- DUNS number
- 948497578
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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