FDA Product Code
FDA Product Code GWQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1400
510(k) Clearances — 189 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K961642 | MEDILOG MR95 | Oxford Instruments, Plc. | 1997-01-17 | Traditional | PDF ↗ |
| K962447 | EQUINOX DIGITAL EEG SYSTEM | Physiometrix, Inc. | 1996-12-12 | Traditional | PDF ↗ |
| K962157 | MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM | Physiometrix, Inc. | 1996-11-25 | Traditional | PDF ↗ |
| K954954 | CEEGRAPH TRAVELER AMBULATORY EEG RECORDER | Bio-Logic Systems Corp. | 1996-01-25 | Traditional | PDF ↗ |
| K953449 | MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS | Physiometrix, Inc. | 1995-10-12 | Traditional | PDF ↗ |
| K946094 | CADWELL EASY AMBULATORY EEG | Cadwell Laboratories, Inc. | 1995-09-12 | Traditional | PDF ↗ |
| K951507 | PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE | Neuroconcepts, Inc. | 1995-07-14 | Traditional | PDF ↗ |
| K944678 | NIHON KOHDEN ELECTROENCEPHALOGRAPH | Nihon Kohden America, Inc. | 1995-05-22 | Traditional | PDF ↗ |
| K941551 | THE VANGUARD SYSTEM | Cleveland Clinic Foundation | 1995-01-13 | Traditional | PDF ↗ |
| K934670 | DG 3P SYSTEM | Medelec , Ltd. | 1994-05-25 | Traditional | PDF ↗ |
| K932407 | CADWELL EASY WRITER AND EASY READER | Cadwell Laboratories, Inc. | 1994-03-22 | Traditional | PDF ↗ |
| K933233 | CEEGRAPH, MODIFICATION | Bio-Logic Systems Corp. | 1994-03-03 | Traditional | PDF ↗ |
| K932842 | SPACELABS MEDICAL MODEL 90481 EEG MODULE | Spacelabs Medical, Inc. | 1994-03-02 | Traditional | PDF ↗ |
| K933951 | VIDEO EEG OPTION MODIFICATION | Esaote Biomedica Spa | 1994-02-03 | Traditional | PDF ↗ |
| K930080 | E*NET NEUROMONITORING SYSTEM | Physiometrix, Inc. | 1993-10-19 | Traditional | PDF ↗ |
| K924179 | EEG MODEL 24/32 | Lama Engineering, Inc. | 1993-06-22 | Traditional | PDF ↗ |
| K921138 | NICOLET ULTRASOM ACQUISITION STATION | Nicolet Instrument Corp. | 1993-05-14 | Traditional | PDF ↗ |
| K925838 | TELEFACTOR D/EEG-32 | Grass-Telefactor Product Group | 1993-04-30 | Traditional | PDF ↗ |
| K923894 | YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH | Biosound, Inc. | 1993-03-10 | Traditional | PDF ↗ |
| K923860 | THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR | Biosound, Inc. | 1993-02-04 | Traditional | PDF ↗ |
| K923950 | THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH | Biosound, Inc. | 1993-01-26 | Traditional | PDF ↗ |
| K921927 | NICOLET VOYAGEUR | Nicolet Instrument Corp. | 1992-11-05 | Traditional | PDF ↗ |
| K922548 | MEDELEC 2110 AND 2114 EEG | Medelec Intl. Corp. | 1992-11-03 | Traditional | PDF ↗ |
| K921485 | LA MONT VIDEO PATIENT MONITORING SYSTEM | Medical Systems Corp. | 1992-10-22 | Traditional | PDF ↗ |
| K920127 | ELECTROENCEPHALOGRAPH RECORDING SYSTEM | Medelec Intl. Corp. | 1992-06-10 | Traditional | PDF ↗ |
| K915096 | NEUROFAX EEG 5532 | Nihon Kohden America, Inc. | 1992-03-11 | Traditional | PDF ↗ |
| K914571 | NEUROTRAC II | Moberg Medical, Inc. | 1992-01-30 | Traditional | PDF ↗ |
| K910972 | WALTER GRAPHTEK | Inomed Medizintechnik GmbH | 1991-10-02 | Traditional | PDF ↗ |
| K911229 | PHOENIX DIGITAL EEG SYSTEM | Dantec Medical, Inc. | 1991-09-30 | Traditional | PDF ↗ |
| K910279 | MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER | New England Medical Instruments, Inc. | 1991-09-04 | Traditional | PDF ↗ |
| K910945 | HORIZON 2000 EEG MONITORING OPTION | Mennen Medical, Inc. | 1991-08-15 | Traditional | PDF ↗ |
| K905435 | UNIQUANT | Neuroconcepts, Inc. | 1991-07-22 | Traditional | PDF ↗ |
| K904269 | NEUROSEARCH-24 OR NRS-24 | Lexicor Medical Technology, Inc. | 1991-06-04 | Traditional | PDF ↗ |
| K904763 | MENTOR EEG SYSTEM | Oxford Medilog, Inc. | 1991-04-10 | Traditional | PDF ↗ |
| K902550 | EEG-5400 SERIES | Nihon Kohden America, Inc. | 1991-03-19 | Traditional | PDF ↗ |
| K902752 | NEURITOR 2001 | Imexco General , Ltd. | 1990-12-04 | Traditional | PDF ↗ |
| K903004 | EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH | Teca, Inc. | 1990-11-15 | Traditional | PDF ↗ |
| K901549 | CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE. | Cns, Inc. | 1990-10-24 | Traditional | PDF ↗ |
| K896942 | SPACELABS MODEL 90480 EEG MODULE | Spacelabs, Inc. | 1990-03-08 | Traditional | PDF ↗ |
| K896666 | P460, DG32 ELECTROENCEPHALOGRAPH | Teca, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K894044 | ACTILLUME | Ambulatory Monitoring, Inc. | 1989-12-22 | Traditional | PDF ↗ |
| K895125 | CEEGRAPH | Bio-Logic Systems Corp. | 1989-12-22 | Traditional | PDF ↗ |
| K894276 | CADWELL FREEDOM EEG DEVICE | Cadwell Laboratories, Inc. | 1989-09-29 | Traditional | PDF ↗ |
| K890881 | TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS | Teca, Inc. | 1989-03-23 | Traditional | PDF ↗ |
| K884537 | AE-800PA EEG MODULE | Nihon Kohden America, Inc. | 1988-12-29 | Traditional | PDF ↗ |
| K883557 | NEUROWAVE SYSTEM 2 | Durden Enterprises, Inc. | 1988-12-16 | Traditional | PDF ↗ |
| K870815 | KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265 | Kontron Instruments, Inc. | 1988-02-01 | Traditional | PDF ↗ |
| K874796 | MODEL EEG 4400 WITH OPTIONAL ACCESSORIES | Nihon Kohden America, Inc. | 1988-01-19 | Traditional | PDF ↗ |
| K873535 | NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM | Nicolet Biomedical Instruments | 1987-10-26 | Traditional | PDF ↗ |
| K872183 | AMBULATORY EEG PLAYBACK | Cadwell Laboratories, Inc. | 1987-07-21 | Traditional | PDF ↗ |
| K871500 | MODEL 5000 AMBULATORY MONITORING SYSTEM | Oxford Medilog, Inc. | 1987-07-01 | Traditional | PDF ↗ |
| K870432 | A1-A2 AMBULATORY EEG CASSETTE RECORDER | Grass-Telefactor Product Group | 1987-05-08 | Traditional | PDF ↗ |
| K870263 | NEUROMAPPER 1620 | Neuroscience, Inc. | 1987-04-10 | Traditional | PDF ↗ |
| K864928 | BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER | Bio-Scan, Inc. | 1987-03-31 | Traditional | PDF ↗ |
| K863193 | SENTINEL 4 EEG ANALYZER | Axon Systems, Inc. | 1986-12-02 | Traditional | PDF ↗ |
| K863124 | MODEL 8 EEG PREAMPLIFIER | Micro Tronics Corp. | 1986-11-18 | Traditional | PDF ↗ |
| K863749 | TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH | Teca, Inc. | 1986-10-06 | Traditional | PDF ↗ |
| K854663 | NEUROFAX 7310 SERIES (EEG) | Nihon Kohden America, Inc. | 1986-08-20 | Traditional | PDF ↗ |
| K860456 | MODEL 9000 RECORDING & ELECTROPHYSIOLOGICAL SYSTEM | Oxford Medilog, Inc. | 1986-08-11 | Traditional | PDF ↗ |
| K854030 | WRIST ACTIGRAPH | Ambulatory Monitoring, Inc. | 1986-06-25 | Traditional | PDF ↗ |
| K854268 | DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER | Del Mar Avionics | 1986-03-27 | Traditional | PDF ↗ |
| K851232 | TECA MONTAGE II | Teca, Inc. | 1985-06-13 | Traditional | PDF ↗ |
| K850418 | BUSHEL OFF-HEAD PREAMPLIFIER | Oxford Medilog, Inc. | 1985-06-13 | Traditional | PDF ↗ |
| K850259 | ELECTROENCEPHALOGRAPH EEG | Nicolet Biomedical Instruments | 1985-04-11 | Traditional | PDF ↗ |
| K842784 | CEREGROTRAC | Advanced Instruments, Inc. | 1985-01-10 | Traditional | PDF ↗ |
| K841653 | DEL MAR AVIONICS 5509 NEURO-SCANNER | Del Mar Avionics | 1984-12-03 | Traditional | PDF ↗ |
| K842714 | EEG-4300 W/OPTINAL ACCESS. EEG 4314 & | Nihon Kohden America, Inc. | 1984-09-25 | Traditional | PDF ↗ |
| K841683 | Q.P. PREAMPLIFIER SYS | Bio-Scan, Inc. | 1984-06-07 | Traditional | PDF ↗ |
| K841684 | BIO/SCAN BIOLOG CASSETTE RECORDER | Bio-Scan, Inc. | 1984-06-07 | Traditional | PDF ↗ |
| K831324 | EEG 42/2P ELECTRO ENCEPHALOGRAPH | Nihon Kohden America, Inc. | 1983-05-27 | Traditional | PDF ↗ |
| K830295 | MEDILOG 9000 SYSTEM | Oxford Medilog, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K823140 | ELECTROENCEPHALOGRAPH | Nihon Kohden America, Inc. | 1982-12-07 | Traditional | PDF ↗ |
| K823116 | NEUROTRAC | Interspec, Inc. | 1982-12-07 | Traditional | PDF ↗ |
| K822700 | DEL MAR MODEL 5500 EEG SCANNER | Del Mar Avionics | 1982-10-04 | Traditional | PDF ↗ |
| K820779 | OTE BIOMEDICAL #1296 - 16 CHAN. RECORD | Del Mar Avionics | 1982-04-26 | Traditional | PDF ↗ |
| K820605 | OTE BIOMEDICA NEUROGRAPH 18 | Del Mar Avionics | 1982-03-23 | Traditional | PDF ↗ |
| K820604 | OTE BIOMEDICA NEUROGRAPH 9 | Del Mar Avionics | 1982-03-23 | Traditional | PDF ↗ |
| K820603 | OTE BIOMEDICA NEUROGRAPH 14 | Del Mar Avionics | 1982-03-23 | Traditional | PDF ↗ |
| K820066 | ELECTROENCEPHALOGRAPHS EEG-5208,5210 | Nihon Kohden America, Inc. | 1982-02-04 | Traditional | PDF ↗ |
| K802887 | MODEL EEG 4221 | Nihon Kohden America, Inc. | 1980-12-16 | Traditional | PDF ↗ |
| K802296 | MINGOGRAF EEG10 | Siemens Corp. | 1980-10-03 | Traditional | PDF ↗ |
| K802292 | MINGOGRAF EEG21 | Siemens Corp. | 1980-10-03 | Traditional | PDF ↗ |
| K791234 | MODEL EEG-4217 ELECTROENCEPHALOGRAPH | Nihon Kohden America, Inc. | 1979-09-12 | Traditional | PDF ↗ |
| K791233 | MODEL EEG-4214 ELECTROENCEPHALOGRAPH | Nihon Kohden America, Inc. | 1979-09-12 | Traditional | PDF ↗ |
| K791150 | ELECTROENCEPHALOGRAPHS MODELS 7209,7213 | Nihon Kohden America, Inc. | 1979-09-12 | Traditional | PDF ↗ |
| K781129 | ACCESSORY TO 4-24 RECORDER | Oxford Medilog, Inc. | 1978-08-31 | Traditional | PDF ↗ |
| K781041 | ELECTROENCEPHALOGRAPH ACCUTRACE 100 | Beckman Instruments, Inc. | 1978-06-28 | Traditional | PDF ↗ |
| K781005 | ELECTROENCEPHALOGRAPH ACCUTRATE 200 | Beckman Instruments, Inc. | 1978-06-28 | Traditional | PDF ↗ |
| K770246 | ISOLATED EEG AMPLIFIER MODULE | Mennen Greatbatch Electonics | 1977-02-14 | Traditional | PDF ↗ |
Product code GWQ · Class II · Neurology. Data: openFDA.