GWS — Analyzer, Spectrum, Electroencephalogram Signal Class I
FDA product code GWS covers "Analyzer, Spectrum, Electroencephalogram Signal", a Class I medical device regulated under 21 CFR 882.1420. Submissions are reviewed by the Neurology panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GWS
- Device Class
- Class I
- Regulation Number
- 882.1420
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K974718 | persyst development | PERSYST PRISM | March 9, 1998 |
| K925735 | bio-scan | EEG ANALYZER | December 3, 1993 |
| K912938 | stellate systems | RHYTHM | July 30, 1991 |
| K894629 | nicolet instrument | NICOLET BEAM II SYSTEM | March 9, 1990 |
| K871931 | neuroscience | ISTAT SOFTWARE | October 13, 1987 |
| K871480 | grass-telefactor product group | STD-228 SPECTRAL TREND DISPLAY | May 1, 1987 |
| K854662 | nihon kohden america | OEE_7102 EEG/TREND MONITOR | August 20, 1986 |
| K860829 | cns | CNS 4/8 AND CT 48.1 SOFTWARE | May 29, 1986 |
| K854160 | cns | CNS-16 & LTM 1.0 SOFTWARE | January 10, 1986 |
| K850430 | neuroscience | NEUROSCIENCE MAP-10 EEG | July 17, 1985 |
| K844481 | teca | NEUROLAB II | May 20, 1985 |
| K844015 | cns | CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE | December 17, 1984 |
| K803233 | dade medical | MEUROMETRICS MONITOR | January 12, 1981 |
| K800452 | neurometrics | NEUROMETRICS MONITOR | April 2, 1980 |
| K800001 | bik foundation | MINI-CEARS COMPUTER (MODEL 1) | January 31, 1980 |