Amplifier, Physiological Signal
Regulation 882.1835
0510(k)s in 12 months (53 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in GWL
| Company | 510(k)s | Recalls |
|---|---|---|
| Eb Neuro S.P.A. | 8 | 0 |
| Blackrock Microsystems | 1 | 2 |
| G.Tec Medical Engineering GmbH | 3 | 0 |
| Nihon Kohden America, Inc. | 3 | 0 |
| Honeywell, Inc. | 2 | 0 |
| I2s Micro Implantable Systems, LLC | 1 | 1 |
| Intelligent Hearing Systems | 2 | 0 |
| Neurotronics, Inc. | 2 | 0 |
| Tms International BV | 2 | 0 |
| Allergan, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 12, 2025 | K243746 | Delphi Amplifier Quantalx Neroscience, IL | GWL |
| Dec 12, 2024 | K242832 | NExT Station; NExT Station Advanced Eb Neuro S.P.A., IT | GWL |
| Sep 4, 2024 | K242305 | BE Plus PRO, Neurotravel LIGHT Eb Neuro S.P.A., IT | GWL |
| Sep 4, 2024 | K240646 | DreamClear Somnomed Technologies Inc., Doing Business AS Remware | GWL |
| Feb 4, 2024 | K232210 | X-trodes System M X-Trodes, IL | GWL |
| Oct 11, 2023 | K230148 | Vlab Dormotech Medical, Ltd., IL | GWL |
| Jun 1, 2023 | K223676 | SomniCheck Brainmatterz, LLC | GWL |
| Jul 15, 2022 | K220631 | NomadAir PMU810 Neurotronics, Inc. | GWL |
| May 20, 2021 | K203331 | Quick-20m Cgx, LLC | GWL |
| Feb 10, 2021 | K202174 | Digital NeuroPort Biopotential Signal Processing System Blackrock Microsystems | GWL |
| Dec 27, 2020 | K201747 | 8-CH Electroencephalography Amplifier Hipposcreen Neurotech Corp., TW | GWL |
| Mar 30, 2018 | K172312 | eego amplifiers Eemagine Medical Imaging Solutions GmbH, DE | GWL |
| Oct 6, 2017 | K171397 | Sienna Ultimate Wireless Amplifier Ems Handels Gesellschaft M.B.H., AT | GWL |
| Jul 5, 2017 | K171669 | g.Nautilus PRO G.Tec Medical Engineering GmbH, AT | GWL |
| Oct 23, 2015 | K151600 | R-40 EEG Amplifier Lifelines , Ltd., GB | GWL |
| Feb 26, 2014 | K133517 | NEMUS 2 SYSTEM Eb Neuro S.P.A. | GWL |
| Dec 20, 2012 | K123255 | g.HIamp G.Tec Medical Engineering GmbH, AT | GWL |
| Aug 3, 2012 | K121996 | BE PLUS LTM AMPLIFIER GWI AMPLIFIER Eb Neuro S.P.A. | GWL |
| Apr 8, 2011 | K103140 | NICOLET WIRELESS EEG Carefusion 209, Inc. | GWL |
| Mar 18, 2010 | K092699 | NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 Neurotronics, Inc. | GWL |
| May 28, 2009 | K090957 | BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM I2s Micro Implantable Systems, LLC | GWL |
| May 27, 2009 | K083322 | NEUROMETRIX BIOAMPLIFIER Neurometrix, Inc. | GWL |
| Mar 22, 2007 | K063599 | PORTI 7 PHYSIOLOGICAL AMPLIFIER Tms International BV | GWL |
| May 30, 2006 | K060374 | REFA, PHYSIOLOGICAL AMPLIFIER Tms International BV | GWL |
| May 2, 2006 | K060803 | G.USBAMP G.Tec Medical Engineering GmbH, AT | GWL |
| Jan 24, 2006 | K053606 | BE PLUS / AURA-LTM64 AMPLIFIER Eb Neuro S.P.A. | GWL |
| Sep 14, 2005 | K051852 | SINGLE AMPLIFIER FOR BOTOX Allergan, Inc. | GWL |
| Aug 31, 2005 | K052060 | OPTI-AMP DC-POWERED Intelligent Hearing Systems | GWL |
| Jun 1, 2004 | K041198 | NIC36 AMPLIFIER Eb Neuro S.P.A. | GWL |
| Feb 18, 2004 | K040113 | SANDMAN SD20 AMPLIFIER Eb Neuro S.P.A. | GWL |
| Jan 5, 2001 | K003154 | MIZAR, BASIS BE, SANDMAN DIGITAL Eb Neuro S.P.A. | GWL |
| Oct 2, 1997 | K972515 | SENSOR AMPLIFIER Pro-Tech Services, Inc. | GWL |
| Dec 12, 1996 | K963669 | GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM Astro-Med, Inc. | GWL |
| Oct 26, 1994 | K943673 | MMC AMPLIFIER Melville Software , Ltd., CA | GWL |
| Jan 10, 1992 | K914876 | OPTI-AMP Intelligent Hearing Systems | GWL |
| Oct 18, 1991 | K912436 | AM-PAK Cns, Inc. | GWL |
| Feb 7, 1991 | K901797 | THE WONDER BOX Micro Tronics Corp. | GWL |
| Jan 18, 1991 | K904222 | VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER Telediagnostic Systems, Inc. | GWL |
| Feb 16, 1990 | K900063 | MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA) Bio-Feedback Systems, Inc. | GWL |
| Feb 27, 1989 | K884071 | AMPLAID EMG15 Amplus Corp. | GWL |
| Sep 30, 1988 | K881177 | MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD Nihon Kohden America, Inc. | GWL |
| Aug 18, 1988 | K880773 | THE VENUS SYSTEM Neuroscientific Corp. | GWL |
| Sep 30, 1987 | K870794 | MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER Nihon Kohden America, Inc. | GWL |
| Jul 16, 1987 | K871678 | NICOLET AMP 6R11 SYSTEM Nicolet Biomedical Instruments | GWL |
| Aug 25, 1986 | K860289 | PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER Professional Health Technologies, Inc. | GWL |
| Aug 20, 1986 | K861014 | AMPLAID MK15 (EVOKED POTENTIAL SYSTEM) Amplaid USA, Inc. | GWL |
| Jun 7, 1984 | K841612 | NEUROPACK II 5100 Nihon Kohden America, Inc. | GWL |
| Nov 28, 1983 | K833413 | COMPUTERSCOPE CPS-ABR Rc Electronics, Inc. | GWL |
| Jul 2, 1982 | K821250 | METRACO EVOKED POTENTIAL SYSTEM Metraco, Inc. | GWL |
| Dec 1, 1978 | K781743 | RESPONSE SYSTEM, TN-3000 Tracor Instruments, Inc. | GWL |
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