Part 882 Subpart B—Neurological Diagnostic Devices
FDA submissions for Part 882 Subpart B—Neurological Diagnostic Devices in the Neurology (NE) review panel, including product codes and regulations.
Section range: §§ 882.1020–882.1950
CFR Part: 882
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| GZM | Analyzer, Rigidity | 882.1020 | 2 | 0 |
| GWW | Ataxiagraph | 882.1030 | 1 | 0 |
| PTB | Ataxiagraph With Interpretive Software | 882.1030 | 1 | 0 |
| GWI | Discriminator, Two-Point | 882.1200 | 1 | 2 |
| LLN | Device, Vibration Threshold Measurement | 882.1200 | 1 | 13 |
| LQW | Test, Temperature Discrimination | 882.1200 | 1 | 3 |
| GXW | Echoencephalograph | 882.1240 | 2 | 7 |
| GYB | Media, Electroconductive | 882.1275 | 2 | 69 |
| GYC | Electrode, Cortical | 882.1310 | 2 | 32 |
| GXY | Electrode, Cutaneous | 882.1320 | 2 | 432 |
| GZL | Electrode, Depth | 882.1330 | 2 | 58 |
| GZK | Electrode, Nasopharyngeal | 882.1340 | 2 | 2 |
| GXZ | Electrode, Needle | 882.1350 | 2 | 53 |
| SEM | Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring | 882.1360 | 2 | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 882.1400 | 2 | 188 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 882.1400 | 2 | 54 |
| OLU | Normalizing Quantitative Electroencephalograph Software | 882.1400 | 2 | 12 |
| OLV | Standard Polysomnograph With Electroencephalograph | 882.1400 | 2 | 64 |
| OLW | Index-Generating Electroencephalograph Software | 882.1400 | 2 | 38 |
| OLX | Source Localization Software For Electroencephalograph Or Magnetoencephalograph | 882.1400 | 2 | 24 |
| OLY | Magnetoencephalograph | 882.1400 | 2 | 6 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 882.1400 | 2 | 36 |
| OMA | Amplitude-Integrated Electroencephalograph | 882.1400 | 2 | 16 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 882.1400 | 2 | 41 |
| OMC | Reduced- Montage Standard Electroencephalograph | 882.1400 | 2 | 28 |
| ORT | Burst Suppression Detection Software For Electroencephalograph | 882.1400 | 2 | 1 |
| SFK | Respiratory Effort Belt For Polysomnography | 882.1400 | 2 | 1 |
| GYA | Tester, Electrode/Lead, Electroencephalograph | 882.1410 | 1 | 5 |
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | 882.1420 | 1 | 15 |
| GWR | Generator, Electroencephalograph Test Signal | 882.1430 | 1 | 0 |
| NCG | Neuropsychiatric Interpretative Electroencephalograph Assessment Aid | 882.1440 | 2 | 3 |
| PIW | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid | 882.1450 | 2 | 9 |
| QWT | Prognostic Assessment Software Of Mild Cognitive Impairment | 882.1454 | 2 | 1 |
| QEA | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid | 882.1455 | 2 | 6 |
| GWN | Nystagmograph | 882.1460 | 2 | 59 |
| PKQ | Computerized Cognitive Assessment Aid | 882.1470 | 2 | 3 |
| PTY | Computerized Cognitive Assessment Aid, Exempt | 882.1470 | 2 | 0 |
| POM | Computerized Cognitive Assessment Aid For Concussion | 882.1471 | 2 | 8 |
| SGB | Pain Assessment Software In Non-Communicative Adults | 882.1472 | 2 | 1 |
| GWG | Endoscope, Neurological | 882.1480 | 2 | 91 |
| QPF | Pediatric Autism Spectrum Disorder Diagnosis Aid | 882.1491 | 2 | 6 |
| GXB | Esthesiometer | 882.1500 | 1 | 7 |
| GWX | Fork, Tuning | 882.1525 | 1 | 4 |
| GZO | Device, Galvanic Skin Response Measurement | 882.1540 | 2 | 26 |
| JXE | Device, Nerve Conduction Velocity Measurement | 882.1550 | 2 | 27 |
| HCJ | Device, Skin Potential Measurement | 882.1560 | 2 | 2 |
| PNA | Evoked Photon Image Capture Device | 882.1561 | 1 | 1 |
| QSL | Brain Temperature Measurement System | 882.1565 | 2 | 1 |
| HCS | Device, Temperature Measurement, Direct Contact, Powered | 882.1570 | 2 | 8 |
| POS | Physiological Signal Based Seizure Monitoring System | 882.1580 | 2 | 10 |
| GXS | Monitor, Alpha | 882.1610 | 2 | 0 |
| GWM | Device, Monitoring, Intracranial Pressure | 882.1620 | 2 | 105 |
| PSP | Intracranial Pressure & Temperature Monitoring Kit | 882.1620 | 2 | 0 |
| POP | Cranial Motion Measurement Device | 882.1630 | 2 | 2 |
| GWZ | Percussor | 882.1700 | 1 | 11 |
| GWY | Pinwheel | 882.1750 | 1 | 5 |
| PVP | Neurological Test Kit | 882.1750 | 1 | 0 |
| JXF | Plethysmograph, Ocular | 882.1790 | 3 | 0 |
| GZN | Rheoencephalograph | 882.1825 | 3 | 0 |
| GWL | Amplifier, Physiological Signal | 882.1835 | 2 | 53 |
| GWK | Conditioner, Signal, Physiological | 882.1845 | 2 | 23 |
| GYE | Encephalogram Telemetry System | 882.1855 | 2 | 20 |
| SFN | Non-Invasive Evoked Response Brain Stimulator | 882.1860 | 2 | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 882.1870 | 2 | 139 |
| NTU | Evoked Potential Stimulator, Thermal | 882.1870 | 2 | 3 |
| SDX | Neuromuscular Stimulator And Exercise Evaluation System | 882.1871 | 2 | 1 |
| GZP | Stimulator, Mechanical, Evoked Response | 882.1880 | 2 | 2 |
| GWE | Stimulator, Photic, Evoked Response | 882.1890 | 2 | 49 |
| GWJ | Stimulator, Auditory, Evoked Response | 882.1900 | 2 | 76 |
| GXX | Block, Test, Ultrasonic Scanner Calibration | 882.1925 | 1 | 3 |
| GYD | Transducer, Tremor | 882.1950 | 2 | 12 |
