FDA Product Code IKN: Electromyograph, Diagnostic
Leading manufacturers include Teca, Inc., Nihon Kohden America, Inc. and Excel Tech. , Ltd..
75
Total
75
Cleared
139d
Avg days
1977
Since
FDA 510(k) Cleared Electromyograph, Diagnostic Devices (Product Code IKN)
75 devices
Cleared
Oct 28, 2005
XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059
Excel Tech. , Ltd.
Neurology
85d
Cleared
Jan 06, 2003
NIM-PRS
Medtronic Xomed, Inc.
Neurology
11d
Cleared
Jun 28, 2001
NEUROPACK MICRO, MODEL MED-9100A SERIES
Nihon Kohden America, Inc.
Neurology
121d
Cleared
Apr 30, 1998
TOENNIES NEUROSCREEN SYSTEM
Erich Jaeger, Inc.
Neurology
307d
Cleared
Nov 07, 1995
EXCEL EMG
Excel Tech. , Ltd.
Neurology
607d
Cleared
Jul 02, 1993
NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
Bio-Logic Systems Corp.
Neurology
161d
Cleared
Mar 02, 1993
PHASIS ELECTROMYOGRAPH
Biosound, Inc.
Neurology
279d
Cleared
Mar 20, 1990
EMG NAVIGATOR & EMG TRAVELER
Bio-Logic Systems Corp.
Neurology
329d
Cleared
Dec 29, 1986
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
Chattanooga Group, Inc.
Neurology
34d
Cleared
Jan 14, 1983
EMG MODULES FOR POLYGRAPH SYSTEM
Nihon Kohden America, Inc.
Neurology
43d
Cleared
Oct 06, 1982
O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381
Del Mar Avionics
Neurology
37d
Cleared
Sep 07, 1982
ANESTHESIA & BRAIN MONITOR
Datex Division Instrumentarium Corp.
Neurology
71d
Cleared
Oct 13, 1981
TECA #TE 8
Teca, Inc.
Neurology
18d
Cleared
Nov 26, 1980
TECA MODEL-10 ELECTROMYOGRAPH
Teca, Inc.
Neurology
35d
Cleared
Apr 21, 1980
CADWELL 7200
Cadwell Laboratories, Inc.
Neurology
28d
Cleared
Aug 16, 1979
CADWELL 7000 ELECTROMYOGRAPH MACHINE
Cadwell Laboratories, Inc.
Neurology
41d
Cleared
Sep 20, 1978
TECA MODEL B9 ELECTROMYOGRAPH
Teca, Inc.
Neurology
36d