Atlas FDA

GWL

53 FDA 510(k) clearances · Product code

97 daysmedian time to decision
197 days90th percentile
53clearances measured

FDA profile

Official device name
Amplifier, Physiological Signal
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1835
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2002: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Delphi Amplifier (K243746)Quantalx Neroscience2025-03-12
NExT Station; NExT Station Advanced (K242832)Eb Neuro S.P.A.2024-12-12
BE Plus PRO, Neurotravel LIGHT (K242305)Eb Neuro S.P.A.2024-09-04
DreamClear (K240646)Somnomed Technologies Inc., Doing Business AS Remware2024-09-04
X-trodes System M (K232210)X-Trodes2024-02-04
Vlab (K230148)Dormotech Medical, Ltd.2023-10-11
SomniCheck (K223676)Brainmatterz, LLC2023-06-01
NomadAir PMU810 (K220631)Neurotronics, Inc.2022-07-15
Quick-20m (K203331)Cgx, LLC2021-05-20
Digital NeuroPort Biopotential Signal Processing System (K202174)Blackrock Microsystems2021-02-10
8-CH Electroencephalography Amplifier (K201747)Hipposcreen Neurotech Corp.2020-12-27
eego amplifiers (K172312)Eemagine Medical Imaging Solutions GmbH2018-03-30
Sienna Ultimate Wireless Amplifier (K171397)Ems Handels Gesellschaft M.B.H.2017-10-06
g.Nautilus PRO (K171669)G.Tec Medical Engineering GmbH2017-07-05
R-40 EEG Amplifier (K151600)Lifelines , Ltd.2015-10-23
NEMUS 2 SYSTEM (K133517)Eb Neuro S.P.A.2014-02-26
g.HIamp (K123255)G.Tec Medical Engineering GmbH2012-12-20
BE PLUS LTM AMPLIFIER GWI AMPLIFIER (K121996)Eb Neuro S.P.A.2012-08-03
NICOLET WIRELESS EEG (K103140)Carefusion 209, Inc.2011-04-08
NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 (K092699)Neurotronics, Inc.2010-03-18
BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM (K090957)I2s Micro Implantable Systems, LLC2009-05-28
NEUROMETRIX BIOAMPLIFIER (K083322)Neurometrix, Inc.2009-05-27
PORTI 7 PHYSIOLOGICAL AMPLIFIER (K063599)Tms International BV2007-03-22
REFA, PHYSIOLOGICAL AMPLIFIER (K060374)Tms International BV2006-05-30
G.USBAMP (K060803)G.Tec Medical Engineering GmbH2006-05-02
BE PLUS / AURA-LTM64 AMPLIFIER (K053606)Eb Neuro S.P.A.2006-01-24
SINGLE AMPLIFIER FOR BOTOX (K051852)Allergan, Inc.2005-09-14
OPTI-AMP DC-POWERED (K052060)Intelligent Hearing Systems2005-08-31
NIC36 AMPLIFIER (K041198)Eb Neuro S.P.A.2004-06-01
SANDMAN SD20 AMPLIFIER (K040113)Eb Neuro S.P.A.2004-02-18
MIZAR, BASIS BE, SANDMAN DIGITAL (K003154)Eb Neuro S.P.A.2001-01-05
SENSOR AMPLIFIER (K972515)Pro-Tech Services, Inc.1997-10-02
GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM (K963669)Astro-Med, Inc.1996-12-12
MMC AMPLIFIER (K943673)Melville Software , Ltd.1994-10-26
OPTI-AMP (K914876)Intelligent Hearing Systems1992-01-10
AM-PAK (K912436)Cns, Inc.1991-10-18
THE WONDER BOX (K901797)Micro Tronics Corp.1991-02-07
VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER (K904222)Telediagnostic Systems, Inc.1991-01-18
MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA) (K900063)Bio-Feedback Systems, Inc.1990-02-16
AMPLAID EMG15 (K884071)Amplus Corp.1989-02-27
MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD (K881177)Nihon Kohden America, Inc.1988-09-30
THE VENUS SYSTEM (K880773)Neuroscientific Corp.1988-08-18
MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER (K870794)Nihon Kohden America, Inc.1987-09-30
NICOLET AMP 6R11 SYSTEM (K871678)Nicolet Biomedical Instruments1987-07-16
PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER (K860289)Professional Health Technologies, Inc.1986-08-25
AMPLAID MK15 (EVOKED POTENTIAL SYSTEM) (K861014)Amplaid USA, Inc.1986-08-20
NEUROPACK II 5100 (K841612)Nihon Kohden America, Inc.1984-06-07
COMPUTERSCOPE CPS-ABR (K833413)Rc Electronics, Inc.1983-11-28
METRACO EVOKED POTENTIAL SYSTEM (K821250)Metraco, Inc.1982-07-02
RESPONSE SYSTEM, TN-3000 (K781743)Tracor Instruments, Inc.1978-12-01
PREAMPLIFIER MODEL 113 (K781289)Princeton Applied Research Corp.1978-09-14
AMPLIFIER OTRONA, MODEL N3A-EMG (K772102)Honeywell, Inc.1977-11-21
AMPLIFIER MODEL N3B-EEG (K771683)Honeywell, Inc.1977-09-20

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