Analyzer, Spectrum, Electroencephalogram Signal
Regulation 882.1420
0510(k)s in 12 months (15 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GWS
| Company | 510(k)s | Recalls |
|---|---|---|
| Cns, Inc. | 3 | 0 |
| Neuroscience, Inc. | 2 | 0 |
| Bik Foundation, Inc. | 1 | 0 |
| Bio-Scan, Inc. | 1 | 0 |
| Dade Medical, Inc. | 1 | 0 |
| Grass-Telefactor Product Group | 1 | 0 |
| Neurometrics | 1 | 0 |
| Nicolet Instrument Corp. | 1 | 0 |
| Nihon Kohden America, Inc. | 1 | 0 |
| Persyst Development Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 9, 1998 | K974718 | PERSYST PRISM Persyst Development Corp. | GWS |
| Dec 3, 1993 | K925735 | EEG ANALYZER Bio-Scan, Inc. | GWS |
| Jul 30, 1991 | K912938 | RHYTHM Stellate Systems, CA | GWS |
| Mar 9, 1990 | K894629 | NICOLET BEAM II SYSTEM Nicolet Instrument Corp. | GWS |
| Oct 13, 1987 | K871931 | ISTAT SOFTWARE Neuroscience, Inc. | GWS |
| May 1, 1987 | K871480 | STD-228 SPECTRAL TREND DISPLAY Grass-Telefactor Product Group | GWS |
| Aug 20, 1986 | K854662 | OEE_7102 EEG/TREND MONITOR Nihon Kohden America, Inc. | GWS |
| May 29, 1986 | K860829 | CNS 4/8 AND CT 48.1 SOFTWARE Cns, Inc. | GWS |
| Jan 10, 1986 | K854160 | CNS-16 & LTM 1.0 SOFTWARE Cns, Inc. | GWS |
| Jul 17, 1985 | K850430 | NEUROSCIENCE MAP-10 EEG Neuroscience, Inc. | GWS |
| May 20, 1985 | K844481 | NEUROLAB II Teca, Inc. | GWS |
| Dec 17, 1984 | K844015 | CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE Cns, Inc. | GWS |
| Jan 12, 1981 | K803233 | MEUROMETRICS MONITOR Dade Medical, Inc. | GWS |
| Apr 2, 1980 | K800452 | NEUROMETRICS MONITOR Neurometrics | GWS |
| Jan 31, 1980 | K800001 | MINI-CEARS COMPUTER (MODEL 1) Bik Foundation, Inc. | GWS |
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