IKN · Class II · 21 CFR 890.1375

FDA Product Code IKN: Electromyograph, Diagnostic

Leading manufacturers include Nicolet Biomedical Instruments, Teca, Inc. and Advantage Medical Division of Cme Telemetrix.

75
Total
75
Cleared
139d
Avg days
1977
Since
75 devices
25–48 of 75
Cleared Mar 02, 1993
PHASIS ELECTROMYOGRAPH
K922488
Biosound, Inc.
Neurology · 279d
Cleared Mar 20, 1990
EMG NAVIGATOR & EMG TRAVELER
K893130
Bio-Logic Systems Corp.
Neurology · 329d
Cleared Mar 22, 1988
MODIFIED NICOLET VIKING SYSTEM
K880573
Nicolet Biomedical Instruments
Neurology · 41d
Cleared Dec 29, 1986
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
K864630
Chattanooga Group, Inc.
Neurology · 34d
Cleared Aug 03, 1984
NICOLET VIKING
K842956
Nicolet Biomedical Instruments
Neurology · 7d
Cleared Jul 20, 1984
CA2000
K842611
Nicolet Biomedical Instruments
Neurology · 15d
Cleared Jul 20, 1984
COMPACT AUDITORY
K842612
Nicolet Biomedical Instruments
Neurology · 15d
Cleared Jul 20, 1984
COMPACT VISUAL
K842613
Nicolet Biomedical Instruments
Neurology · 15d
Cleared Jul 12, 1983
NICOLET EMG SATELLITE
K830702
Nicolet Biomedical Instruments
Neurology · 127d
Cleared Jan 14, 1983
EMG MODULES FOR POLYGRAPH SYSTEM
K823562
Nihon Kohden America, Inc.
Neurology · 43d
Cleared Oct 06, 1982
O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381
K822624
Del Mar Avionics
Neurology · 37d
Cleared Sep 07, 1982
ANESTHESIA & BRAIN MONITOR
K821910
Datex Division Instrumentarium Corp.
Neurology · 71d
Cleared Oct 13, 1981
TECA #TE 8
K812715
Teca, Inc.
Neurology · 18d
Cleared Nov 26, 1980
TECA MODEL-10 ELECTROMYOGRAPH
K802637
Teca, Inc.
Neurology · 35d
Cleared Apr 21, 1980
CADWELL 7200
K800648
Cadwell Laboratories, Inc.
Neurology · 28d
Cleared Aug 16, 1979
CADWELL 7000 ELECTROMYOGRAPH MACHINE
K791235
Cadwell Laboratories, Inc.
Neurology · 41d
Cleared Apr 23, 1979
MODEL 1309 AUDIO MONITOR
K790664
Life-Tech Instruments, Inc.
Neurology · 17d
Cleared Sep 20, 1978
TECA MODEL B9 ELECTROMYOGRAPH
K781399
Teca, Inc.
Neurology · 36d
Cleared May 19, 1978
PRESSURE MODULES MODELS 1855 & 1856
K780541
Life-Tech Instruments, Inc.
Neurology · 46d