IKN · Class II · 21 CFR 890.1375

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
1–24 of 75
Cleared Oct 28, 2005
XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059
K052112
Excel Tech. , Ltd.
Neurology · 85d
Cleared Jan 06, 2003
NIM-PRS
K024316
Medtronic Xomed, Inc.
Neurology · 11d
Cleared Jun 28, 2001
NEUROPACK MICRO, MODEL MED-9100A SERIES
K010590
Nihon Kohden America, Inc.
Neurology · 121d
Cleared Apr 30, 1998
TOENNIES NEUROSCREEN SYSTEM
K972419
Erich Jaeger, Inc.
Neurology · 307d
Cleared Nov 07, 1995
EXCEL EMG
K941144
Excel Tech. , Ltd.
Neurology · 607d
Cleared Jul 02, 1993
NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
K930328
Bio-Logic Systems Corp.
Neurology · 161d
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 Dec 29, 1986
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
K864630
Chattanooga Group, Inc.
Neurology · 34d
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 Sep 20, 1978
TECA MODEL B9 ELECTROMYOGRAPH
K781399
Teca, Inc.
Neurology · 36d

About Product Code IKN - Regulatory Context