Analyzer, Spectrum, Electroencephalogram Signal
The Analyzer, Spectrum, Electroencephalogram Signal is a neurological device that performs spectral frequency analysis of EEG signals, transforming raw brainwave data into frequency components to assist in the evaluation of neurological conditions such as epilepsy, encephalopathy, and sleep disorders. It is an FDA Class 1 device subject to general controls only, with no premarket submission required. This device is eligible for third-party 510(k) review. Regulated under 21 CFR 882.1420 with product code GWS in the Neurology specialty.
Basic Information
- Product Code
- GWS
- Device Class
- FDA class 1
- Regulation Number
- 882.1420
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K974718 | PERSYST PRISM | Mar 09, 1998 | Substantially Equivalent | PERSYST DEVELOPMENT CORP. |
| K925735 | EEG ANALYZER | Dec 03, 1993 | Substantially Equivalent | BIO-SCAN, INC. |
| K912938 | RHYTHM | Jul 30, 1991 | Substantially Equivalent | STELLATE SYSTEMS |
| K894629 | NICOLET BEAM II SYSTEM | Mar 09, 1990 | Substantially Equivalent | NICOLET INSTRUMENT CORP. |
| K871931 | ISTAT SOFTWARE | Oct 13, 1987 | Substantially Equivalent | NEUROSCIENCE, INC. |
| K871480 | STD-228 SPECTRAL TREND DISPLAY | May 01, 1987 | Substantially Equivalent | GRASS-TELEFACTOR PRODUCT GROUP |
| K854662 | OEE_7102 EEG/TREND MONITOR | Aug 20, 1986 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K860829 | CNS 4/8 AND CT 48.1 SOFTWARE | May 29, 1986 | Substantially Equivalent | CNS, INC. |
| K854160 | CNS-16 & LTM 1.0 SOFTWARE | Jan 10, 1986 | Substantially Equivalent | CNS, INC. |
| K850430 | NEUROSCIENCE MAP-10 EEG | Jul 17, 1985 | Substantially Equivalent | NEUROSCIENCE, INC. |
| K844481 | NEUROLAB II | May 20, 1985 | Substantially Equivalent | TECA, INC. |
| K844015 | CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE | Dec 17, 1984 | Substantially Equivalent | CNS, INC. |
| K803233 | MEUROMETRICS MONITOR | Jan 12, 1981 | Substantially Equivalent | DADE MEDICAL, INC. |
| K800452 | NEUROMETRICS MONITOR | Apr 02, 1980 | Substantially Equivalent | NEUROMETRICS |
| K800001 | MINI-CEARS COMPUTER (MODEL 1) | Jan 31, 1980 | Substantially Equivalent | BIK FOUNDATION, INC. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.