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Amplifier, Physiological Signal

FDA product code GWL · 51 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.1835
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-09-20 – 2025-03-12

GWL 2025-03-12

Delphi Amplifier

Applicant Quantalx Neroscience

K number K243746

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GWL 2024-12-12

NExT Station; NExT Station Advanced

Applicant Eb Neuro S.P.A.

K number K242832

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GWL 2024-09-04

BE Plus PRO, Neurotravel LIGHT

Applicant Eb Neuro S.P.A.

K number K242305

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GWL 2024-09-04

DreamClear

Applicant Somnomed Technologies Inc., Doing Business AS Remware

K number K240646

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GWL 2024-02-04

X-trodes System M

Applicant X-Trodes

K number K232210

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GWL 2023-10-11

Vlab

Applicant Dormotech Medical, Ltd.

K number K230148

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GWL 2023-06-01

SomniCheck

Applicant Brainmatterz, LLC

K number K223676

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GWL 2022-07-15

NomadAir PMU810

Applicant Neurotronics, Inc.

K number K220631

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GWL 2021-05-20

Quick-20m

Applicant Cgx, LLC

K number K203331

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GWL 2021-02-10

Digital NeuroPort Biopotential Signal Processing System

Applicant Blackrock Microsystems

K number K202174

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GWL 2020-12-27

8-CH Electroencephalography Amplifier

Applicant Hipposcreen Neurotech Corp.

K number K201747

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GWL 2018-03-30

eego amplifiers

Applicant Eemagine Medical Imaging Solutions GmbH

K number K172312

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GWL 2017-10-06

Sienna Ultimate Wireless Amplifier

Applicant Ems Handels Gesellschaft M.B.H.

K number K171397

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GWL 2017-07-05

g.Nautilus PRO

Applicant G.Tec Medical Engineering GmbH

K number K171669

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GWL 2012-12-20

g.HIamp

Applicant G.Tec Medical Engineering GmbH

K number K123255

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GWL 2012-08-03

BE PLUS LTM AMPLIFIER GWI AMPLIFIER

Applicant Eb Neuro S.P.A.

K number K121996

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GWL 2011-04-08

NICOLET WIRELESS EEG

Applicant Carefusion 209, Inc.

K number K103140

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GWL 2010-03-18

NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800

Applicant Neurotronics, Inc.

K number K092699

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GWL 2009-05-28

BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM

Applicant I2s Micro Implantable Systems, LLC

K number K090957

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GWL 2009-05-27

NEUROMETRIX BIOAMPLIFIER

Applicant Neurometrix, Inc.

K number K083322

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GWL 2007-03-22

PORTI 7 PHYSIOLOGICAL AMPLIFIER

Applicant Tms International BV

K number K063599

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GWL 2006-05-30

REFA, PHYSIOLOGICAL AMPLIFIER

Applicant Tms International BV

K number K060374

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GWL 2006-05-02

G.USBAMP

Applicant G.Tec Medical Engineering GmbH

K number K060803

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GWL 2006-01-24

BE PLUS / AURA-LTM64 AMPLIFIER

Applicant Eb Neuro S.P.A.

K number K053606

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GWL 2005-09-14

SINGLE AMPLIFIER FOR BOTOX

Applicant Allergan, Inc.

K number K051852

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GWL 2005-08-31

OPTI-AMP DC-POWERED

Applicant Intelligent Hearing Systems

K number K052060

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GWL 2004-06-01

NIC36 AMPLIFIER

Applicant Eb Neuro S.P.A.

K number K041198

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GWL 2004-02-18

SANDMAN SD20 AMPLIFIER

Applicant Eb Neuro S.P.A.

K number K040113

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GWL 2001-01-05

MIZAR, BASIS BE, SANDMAN DIGITAL

Applicant Eb Neuro S.P.A.

K number K003154

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GWL 1997-10-02

SENSOR AMPLIFIER

Applicant Pro-Tech Services, Inc.

K number K972515

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GWL 1996-12-12

GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM

Applicant Astro-Med, Inc.

K number K963669

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GWL 1994-10-26

MMC AMPLIFIER

Applicant Melville Software , Ltd.

K number K943673

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GWL 1992-01-10

OPTI-AMP

Applicant Intelligent Hearing Systems

K number K914876

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GWL 1991-10-18

AM-PAK

Applicant Cns, Inc.

K number K912436

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GWL 1991-02-07

THE WONDER BOX

Applicant Micro Tronics Corp.

K number K901797

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GWL 1991-01-18

VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER

Applicant Telediagnostic Systems, Inc.

K number K904222

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GWL 1990-02-16

MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA)

Applicant Bio-Feedback Systems, Inc.

K number K900063

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GWL 1989-02-27

AMPLAID EMG15

Applicant Amplus Corp.

K number K884071

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GWL 1988-09-30

MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD

Applicant Nihon Kohden America, Inc.

K number K881177

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GWL 1988-08-18

THE VENUS SYSTEM

Applicant Neuroscientific Corp.

K number K880773

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GWL 1987-09-30

MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER

Applicant Nihon Kohden America, Inc.

K number K870794

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GWL 1987-07-16

NICOLET AMP 6R11 SYSTEM

Applicant Nicolet Biomedical Instruments

K number K871678

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GWL 1986-08-25

PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER

Applicant Professional Health Technologies, Inc.

K number K860289

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GWL 1986-08-20

AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)

Applicant Amplaid USA, Inc.

K number K861014

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GWL 1984-06-07

NEUROPACK II 5100

Applicant Nihon Kohden America, Inc.

K number K841612

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GWL 1983-11-28

COMPUTERSCOPE CPS-ABR

Applicant Rc Electronics, Inc.

K number K833413

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GWL 1982-07-02

METRACO EVOKED POTENTIAL SYSTEM

Applicant Metraco, Inc.

K number K821250

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GWL 1978-12-01

RESPONSE SYSTEM, TN-3000

Applicant Tracor Instruments, Inc.

K number K781743

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GWL 1978-09-14

PREAMPLIFIER MODEL 113

Applicant Princeton Applied Research Corp.

K number K781289

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GWL 1977-11-21

AMPLIFIER OTRONA, MODEL N3A-EMG

Applicant Honeywell, Inc.

K number K772102

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GWL 1977-09-20

AMPLIFIER MODEL N3B-EEG

Applicant Honeywell, Inc.

K number K771683

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