510(k) K860829
- Device
- CNS 4/8 AND CT 48.1 SOFTWARE
- Applicant
- CNS, INC.
- 510(k) number
- K860829
- Product code
- GWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-05-29
- Date received
- 1986-03-05
- Regulation
- 882.1420
- Classification name
- Analyzer, Spectrum, Electroencephalogram Signal
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- COHEN, MD
- Address
- 7090 Shady Oak Rd. Eden Prairie MN US 55344 55344
FDA Registration Numbers#
- 3013500228
- 3008058135
- 3012528160
- 3013596024
- 3000126629
- 3016618143
- 9610816
- 3009077524
- 3003263092
- 3016701404
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GWS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974718 | PERSYST PRISM | Persyst Development Corp. | 1998-03-09 |
| K925735 | EEG ANALYZER | Bio-Scan, Inc. | 1993-12-03 |
| K912938 | RHYTHM | Stellate Systems | 1991-07-30 |
| K894629 | NICOLET BEAM II SYSTEM | Nicolet Instrument Corp. | 1990-03-09 |
| K871931 | ISTAT SOFTWARE | Neuroscience, Inc. | 1987-10-13 |
| K871480 | STD-228 SPECTRAL TREND DISPLAY | Grass-Telefactor Product Group | 1987-05-01 |
| K854662 | OEE_7102 EEG/TREND MONITOR | Nihon Kohden America, Inc. | 1986-08-20 |
| K854160 | CNS-16 & LTM 1.0 SOFTWARE | Cns, Inc. | 1986-01-10 |
| K850430 | NEUROSCIENCE MAP-10 EEG | Neuroscience, Inc. | 1985-07-17 |
| K844481 | NEUROLAB II | Teca, Inc. | 1985-05-20 |
| K844015 | CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE | Cns, Inc. | 1984-12-17 |
| K803233 | MEUROMETRICS MONITOR | Dade Medical, Inc. | 1981-01-12 |
| K800452 | NEUROMETRICS MONITOR | Neurometrics | 1980-04-02 |
| K800001 | MINI-CEARS COMPUTER (MODEL 1) | Bik Foundation, Inc. | 1980-01-31 |
Legacy Summary#
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FDA Review#
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