Non-Normalizing Quantitative Electroencephalograph Software
Regulation 882.1400
4510(k)s in 12 months (57 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OLT
| Company | 510(k)s | Recalls |
|---|---|---|
| Aspect Medical Systems, Inc. | 2 | 0 |
| Brainz Instruments , Ltd. | 2 | 0 |
| Electrical Geodesics, Inc. | 2 | 0 |
| Infinite Biomedical Technologies | 2 | 0 |
| Kvikna Ehf | 2 | 0 |
| Medelec , Ltd. | 2 | 0 |
| Neuro Scan Labs | 2 | 0 |
| Neurosoft , Ltd. | 2 | 0 |
| Pascall Systems, Inc. | 2 | 0 |
| Stellate Systems | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 7, 1986 | K853420 | CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS Alvar | OLT |
| Aug 16, 1985 | K852587 | CDSA(COLOR DENSITY, SPECTRAL ARRRAY) Tracor Northern, Inc. | OLT |
| Aug 2, 1985 | K850541 | SLEEP STAGER Oxford Medilog, Inc. | OLT |
| Nov 8, 1984 | K843808 | DUAL CHENNEL BRAIN ACTIVITY MONITOR Datex Division Instrumentarium Corp. | OLT |
| Jul 12, 1984 | K841790 | LIFESCAN EEG MONITOR Neurometrics | OLT |
| May 7, 1982 | K820653 | OTE BIOMEDICA BERG FOURIER ANALYZER Del Mar Avionics | OLT |
| Mar 13, 1981 | K810359 | ELECTROENCEPHALOMYOGRAPH Thoracel Research Labs. | OLT |
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