GWL · Class II · 21 CFR 882.1835

FDA Product Code GWL: Amplifier, Physiological Signal

Leading manufacturers include Eb Neuro S.P.A., Nihon Kohden America, Inc. and G.Tec Medical Engineering GmbH.

53
Total
53
Cleared
114d
Avg days
1977
Since
53 devices
25–48 of 53
Cleared May 02, 2006
G.USBAMP
K060803
G.Tec Medical Engineering GmbH
Neurology · 39d
Cleared Jan 24, 2006
BE PLUS / AURA-LTM64 AMPLIFIER
K053606
Eb Neuro S.P.A.
Neurology · 28d
Cleared Sep 14, 2005
SINGLE AMPLIFIER FOR BOTOX
K051852
Allergan, Inc.
Neurology · 68d
Cleared Aug 31, 2005
OPTI-AMP DC-POWERED
K052060
Intelligent Hearing Systems
Neurology · 33d
Cleared Jun 01, 2004
NIC36 AMPLIFIER
K041198
Eb Neuro S.P.A.
Neurology · 25d
Cleared Jan 05, 2001
MIZAR, BASIS BE, SANDMAN DIGITAL
K003154
Eb Neuro S.P.A.
Neurology · 87d
Cleared Oct 02, 1997
SENSOR AMPLIFIER
K972515
Pro-Tech Services, Inc.
Neurology · 91d
Cleared Dec 12, 1996
GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM
K963669
Astro-Med, Inc.
Neurology · 90d
Cleared Sep 30, 1988
MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD
K881177
Nihon Kohden America, Inc.
Neurology · 196d
Cleared Sep 30, 1987
MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER
K870794
Nihon Kohden America, Inc.
Neurology · 216d
Cleared Jul 16, 1987
NICOLET AMP 6R11 SYSTEM
K871678
Nicolet Biomedical Instruments
Neurology · 79d
Cleared Jun 07, 1984
NEUROPACK II 5100
K841612
Nihon Kohden America, Inc.
Neurology · 58d
Cleared Nov 21, 1977
AMPLIFIER OTRONA, MODEL N3A-EMG
K772102
Honeywell, Inc.
Neurology · 14d
Cleared Sep 20, 1977
AMPLIFIER MODEL N3B-EEG
K771683
Honeywell, Inc.
Neurology · 14d