FDA Product Code
FDA Product Code GWS — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1420
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K974718 | PERSYST PRISM | Persyst Development Corp. | 1998-03-09 | Traditional | PDF ↗ |
| K925735 | EEG ANALYZER | Bio-Scan, Inc. | 1993-12-03 | Traditional | PDF ↗ |
| K912938 | RHYTHM | Stellate Systems | 1991-07-30 | Traditional | PDF ↗ |
| K894629 | NICOLET BEAM II SYSTEM | Nicolet Instrument Corp. | 1990-03-09 | Traditional | PDF ↗ |
| K871931 | ISTAT SOFTWARE | Neuroscience, Inc. | 1987-10-13 | Traditional | PDF ↗ |
| K871480 | STD-228 SPECTRAL TREND DISPLAY | Grass-Telefactor Product Group | 1987-05-01 | Traditional | PDF ↗ |
| K854662 | OEE_7102 EEG/TREND MONITOR | Nihon Kohden America, Inc. | 1986-08-20 | Traditional | PDF ↗ |
| K860829 | CNS 4/8 AND CT 48.1 SOFTWARE | Cns, Inc. | 1986-05-29 | Traditional | PDF ↗ |
| K854160 | CNS-16 & LTM 1.0 SOFTWARE | Cns, Inc. | 1986-01-10 | Traditional | PDF ↗ |
| K850430 | NEUROSCIENCE MAP-10 EEG | Neuroscience, Inc. | 1985-07-17 | Traditional | PDF ↗ |
| K844481 | NEUROLAB II | Teca, Inc. | 1985-05-20 | Traditional | PDF ↗ |
| K844015 | CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE | Cns, Inc. | 1984-12-17 | Traditional | PDF ↗ |
| K803233 | MEUROMETRICS MONITOR | Dade Medical, Inc. | 1981-01-12 | Traditional | PDF ↗ |
| K800452 | NEUROMETRICS MONITOR | Neurometrics | 1980-04-02 | Traditional | PDF ↗ |
| K800001 | MINI-CEARS COMPUTER (MODEL 1) | Bik Foundation, Inc. | 1980-01-31 | Traditional | PDF ↗ |
Product code GWS · Class I · Neurology. Data: openFDA.