FDA Product Code
FDA Product Code GWL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1835
510(k) Clearances — 53 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243746 | Delphi Amplifier | Quantalx Neroscience | 2025-03-12 | Traditional | PDF ↗ |
| K242832 | NExT Station; NExT Station Advanced | Eb Neuro S.P.A. | 2024-12-12 | Special | PDF ↗ |
| K240646 | DreamClear | Somnomed Technologies Inc., Doing Business AS Remware | 2024-09-04 | Traditional | PDF ↗ |
| K242305 | BE Plus PRO, Neurotravel LIGHT | Eb Neuro S.P.A. | 2024-09-04 | Special | PDF ↗ |
| K232210 | X-trodes System M | X-Trodes | 2024-02-04 | Traditional | PDF ↗ |
| K230148 | Vlab | Dormotech Medical, Ltd. | 2023-10-11 | Traditional | PDF ↗ |
| K223676 | SomniCheck | Brainmatterz, LLC | 2023-06-01 | Traditional | PDF ↗ |
| K220631 | NomadAir PMU810 | Neurotronics, Inc. | 2022-07-15 | Traditional | PDF ↗ |
| K203331 | Quick-20m | Cgx, LLC | 2021-05-20 | Traditional | PDF ↗ |
| K202174 | Digital NeuroPort Biopotential Signal Processing System | Blackrock Microsystems | 2021-02-10 | Special | PDF ↗ |
| K201747 | 8-CH Electroencephalography Amplifier | Hipposcreen Neurotech Corp. | 2020-12-27 | Traditional | PDF ↗ |
| K172312 | eego amplifiers | Eemagine Medical Imaging Solutions GmbH | 2018-03-30 | Traditional | PDF ↗ |
| K171397 | Sienna Ultimate Wireless Amplifier | Ems Handels Gesellschaft M.B.H. | 2017-10-06 | Traditional | PDF ↗ |
| K171669 | g.Nautilus PRO | G.Tec Medical Engineering GmbH | 2017-07-05 | Traditional | PDF ↗ |
| K151600 | R-40 EEG Amplifier | Lifelines , Ltd. | 2015-10-23 | Traditional | PDF ↗ |
| K133517 | NEMUS 2 SYSTEM | Eb Neuro S.P.A. | 2014-02-26 | Traditional | PDF ↗ |
| K123255 | g.HIamp | G.Tec Medical Engineering GmbH | 2012-12-20 | Traditional | PDF ↗ |
| K121996 | BE PLUS LTM AMPLIFIER GWI AMPLIFIER | Eb Neuro S.P.A. | 2012-08-03 | Special | PDF ↗ |
| K103140 | NICOLET WIRELESS EEG | Carefusion 209, Inc. | 2011-04-08 | Traditional | PDF ↗ |
| K092699 | NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 | Neurotronics, Inc. | 2010-03-18 | Traditional | PDF ↗ |
| K090957 | BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM | I2s Micro Implantable Systems, LLC | 2009-05-28 | Abbreviated | PDF ↗ |
| K083322 | NEUROMETRIX BIOAMPLIFIER | Neurometrix, Inc. | 2009-05-27 | Traditional | PDF ↗ |
| K063599 | PORTI 7 PHYSIOLOGICAL AMPLIFIER | Tms International BV | 2007-03-22 | Special | PDF ↗ |
| K060374 | REFA, PHYSIOLOGICAL AMPLIFIER | Tms International BV | 2006-05-30 | Abbreviated | PDF ↗ |
| K060803 | G.USBAMP | G.Tec Medical Engineering GmbH | 2006-05-02 | Traditional | PDF ↗ |
| K053606 | BE PLUS / AURA-LTM64 AMPLIFIER | Eb Neuro S.P.A. | 2006-01-24 | Special | PDF ↗ |
| K051852 | SINGLE AMPLIFIER FOR BOTOX | Allergan, Inc. | 2005-09-14 | Traditional | PDF ↗ |
| K052060 | OPTI-AMP DC-POWERED | Intelligent Hearing Systems | 2005-08-31 | Special | PDF ↗ |
| K041198 | NIC36 AMPLIFIER | Eb Neuro S.P.A. | 2004-06-01 | Special | PDF ↗ |
| K040113 | SANDMAN SD20 AMPLIFIER | Eb Neuro S.P.A. | 2004-02-18 | Special | PDF ↗ |
| K003154 | MIZAR, BASIS BE, SANDMAN DIGITAL | Eb Neuro S.P.A. | 2001-01-05 | Traditional | PDF ↗ |
| K972515 | SENSOR AMPLIFIER | Pro-Tech Services, Inc. | 1997-10-02 | Traditional | PDF ↗ |
| K963669 | GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM | Astro-Med, Inc. | 1996-12-12 | Traditional | PDF ↗ |
| K943673 | MMC AMPLIFIER | Melville Software , Ltd. | 1994-10-26 | Traditional | PDF ↗ |
| K914876 | OPTI-AMP | Intelligent Hearing Systems | 1992-01-10 | Traditional | PDF ↗ |
| K912436 | AM-PAK | Cns, Inc. | 1991-10-18 | Traditional | PDF ↗ |
| K901797 | THE WONDER BOX | Micro Tronics Corp. | 1991-02-07 | Traditional | PDF ↗ |
| K904222 | VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER | Telediagnostic Systems, Inc. | 1991-01-18 | Traditional | PDF ↗ |
| K900063 | MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA) | Bio-Feedback Systems, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K884071 | AMPLAID EMG15 | Amplus Corp. | 1989-02-27 | Traditional | PDF ↗ |
| K881177 | MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD | Nihon Kohden America, Inc. | 1988-09-30 | Traditional | PDF ↗ |
| K880773 | THE VENUS SYSTEM | Neuroscientific Corp. | 1988-08-18 | Traditional | PDF ↗ |
| K870794 | MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER | Nihon Kohden America, Inc. | 1987-09-30 | Traditional | PDF ↗ |
| K871678 | NICOLET AMP 6R11 SYSTEM | Nicolet Biomedical Instruments | 1987-07-16 | Traditional | PDF ↗ |
| K860289 | PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER | Professional Health Technologies, Inc. | 1986-08-25 | Traditional | PDF ↗ |
| K861014 | AMPLAID MK15 (EVOKED POTENTIAL SYSTEM) | Amplaid USA, Inc. | 1986-08-20 | Traditional | PDF ↗ |
| K841612 | NEUROPACK II 5100 | Nihon Kohden America, Inc. | 1984-06-07 | Traditional | PDF ↗ |
| K833413 | COMPUTERSCOPE CPS-ABR | Rc Electronics, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K821250 | METRACO EVOKED POTENTIAL SYSTEM | Metraco, Inc. | 1982-07-02 | Traditional | PDF ↗ |
| K781743 | RESPONSE SYSTEM, TN-3000 | Tracor Instruments, Inc. | 1978-12-01 | Traditional | PDF ↗ |
| K781289 | PREAMPLIFIER MODEL 113 | Princeton Applied Research Corp. | 1978-09-14 | Traditional | PDF ↗ |
| K772102 | AMPLIFIER OTRONA, MODEL N3A-EMG | Honeywell, Inc. | 1977-11-21 | Traditional | PDF ↗ |
| K771683 | AMPLIFIER MODEL N3B-EEG | Honeywell, Inc. | 1977-09-20 | Traditional | PDF ↗ |
Product code GWL · Class II · Neurology. Data: openFDA.