IKN

Product Code: IKN

Products Classified as IKN

3818

Electromyograph, Diagnostic

Diagnostic Electromyograph.

Total Product Life Cycle (TPLC) Devices

3818

Electromyograph, Diagnostic

Diagnostic Electromyograph.

Pre-market Notifications for IKN

K172743	Natus VikingQuest	Natus Neurology Incorporated
K163150	ViMove2	DORSAVI LTD
K162383	Cadwell Sierra Summit, Cadwell Sierra Ascent	CADWELL INDUSTRIES, INC.
K142494	ViMove	DorsaVi Ltd.
K131094	VIMOVE	DORSA VI PTY. LTD
K123902	PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)	OKTX LLC
K123399	MYOVISION 3.0 WIREFREE SYSTEM	PRECISION BIOMETRICS, INC.
K113074	CMAP PRO	MEDICAL TECHNOLOGIES, INC.
K110048	CERSR ELECTROMYOGRAPHY SYSTEM	SPINEMATRIX, INC.
K102610	FOCUS EMG DEVICE	TELEEMG, LLC USA
K083679	UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1	UROVAL
K073415	NEMUS SYSTEM; NEMUS PC PERIPHERAL	EB NEURO, S.P.A.
K063447	INSIGHT DISCOVERY	FASSTECH
K052112	XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059	EXCEL TECH. LTD.
K033452	CWAS 1000	FASSTECH

Global Unique Device Identification Database

• 00382830043595: Electromyograph, Diagnostic
• 00382830043588: Electromyograph, Diagnostic
• 00382830043571: Electromyograph, Diagnostic
• 00382830043465: Electromyograph, Diagnostic
• 00382830041928: Electromyograph, Diagnostic
• 00382830041744: Electromyograph, Diagnostic
• 00382830041560: Electromyograph, Diagnostic
• 00382830038478: Electromyograph, Diagnostic
• 00382830038188: Electromyograph, Diagnostic
• 00382830037648: Electromyograph, Diagnostic
• 00382830037631: Electromyograph, Diagnostic
• 00382830037556: Electromyograph, Diagnostic
• 00382830037532: Electromyograph, Diagnostic
• 00382830037518: Electromyograph, Diagnostic
• 00382830037457: Electromyograph, Diagnostic

Maude Adverse Events

NIM? 2.0 MAINFRAME - PULSE	MEDTRONIC XOMED INC.	2020-02-12
NIM? 2.0 MAINFRAME - PULSE	MEDTRONIC XOMED INC.	2019-10-23
MEB-9400A	NIHON KOHDEN CORPORATION	2019-10-14
MEB-2300A	NIHON KOHDEN CORPORATION	2019-09-14
NIM? 2.0 MAINFRAME	MEDTRONIC XOMED INC.	2019-04-09
MEB-9400A	NIHON KOHDEN CORPORATION	2019-01-04
EMGELECTROMYOGRAPH, DIAGNOSTIC	UNK	2018-12-17
MEB-9400A	NIHON KOHDEN CORPORATION	2018-12-07
NIM? 2.0 MAINFRAME	MEDTRONIC XOMED INC.	2018-10-10
MEB-9400A	NIHON KOHDEN CORPORATION	2018-05-25
EMG NERVE CONDUCTION	UNK	2018-05-21
NONE	NEUROVISION MEDICAL PRODUCTS INC.	2017-03-10
NIM? 2.0 INTERFACE	MEDTRONIC XOMED INC.	2017-01-20
NATUS EDX ELECTROMYOGRAPH SYSTEM	NATUS NEUROLOGY, INCORPORATED	2016-08-24
NATUS EDX ELECTROMYOGRAPH SYSTEM	NATUS NEUROLOGY, INCORPORATED	2016-08-24
NATUS EDX ELECTROMYOGRAPH SYSTEM	NATUS NEUROLOGY, INCORPORATED	2016-08-24
NATUS EDX ELECTROMYOGRAPH SYSTEM	NATUS NEUROLOGY, INCORPORATED	2016-08-24
NATUS EDX ELECTROMYOGRAPH SYSTEM	NATUS NEUROLOGY, INCORPORATED	2016-08-24
NIM? 2.0 MAINFRAME	MEDTRONIC XOMED INC.	2016-05-16
NIM? 2.0 MAINFRAME	MEDTRONIC XOMED INC.	2016-05-16
NIM? 2.0 MAINFRAME	MEDTRONIC XOMED INC.	2016-04-07
NIM-NEURO? 2.0 MAINFRAME	MEDTRONIC XOMED INC.	2016-03-07
NATUS VIKING SELECT	NATUS NEUROLOGY, INCORPORTAED	2016-02-22
VIKINGQUEST	NATUS NEUROLOGY, INCORPORATED	2016-01-21
NIM? 2.0 MAINFRAME - PULSE	MEDTRONIC XOMED INC.	2015-11-03
NIM? 2.0 MAINFRAME	MEDTRONIC XOMED INC.	2015-08-24
VIKING SELECT	NATUS NEUROLOGY, INCORPORATED	2015-08-12
VIKING SELECT	NATUS NEUROLOGY, INCORPORATED	2015-08-12
VIKING SELECT	NATUS NEUROLOGY, INCORPORATED	2015-08-12
VIKING SELECT	NATUS NEUROLOGY, INCORPORATED	2015-08-12
VIKING SELECT	NATUS NEUROLOGY, INCORPORATED	2015-08-11
VIKING SELECT	NATUS NEUROLOGY, INCORPORTAED	2015-07-30
NATUS VIKING SELECT	NATUS NEUROLOGY, INCORPORTAED	2015-07-21
NICOLET VIKING EDX	NATUS NEUROLOGY INCORPORATED	2015-06-08
NICOLET EDX	NATUS NEUROLOGY, INCORPORATED	2015-05-27
NIM RESPONSE? 2.0 INTERFACE	MEDTRONIC XOMED, INC.	2015-02-17
NIM RESPONSE?	MEDTRONIC XOMED, INC	2015-01-23
MAINFRAME RESPONSE 2.0	MEDTRONIC XOMED, INC.	2014-04-10
MAINFRAME 8252001 NIM-RESPONSE 2.0	MEDTRONIC XOMED, INC.	2014-03-19
DEVICE 8252410 NIM-NEURO 2.0 INTERFACE	MEDTRONIC XOMED INC.	2014-02-21
DEVICE 8252410 NIM-NEURO 2.0 INTERFACE	MEDTRONIC XOMED, INC.	2013-12-30
MAINFRAME 8252401IP NEURO 2.0 W/INCRE	MEDTRONIC XOMED, INC.	2013-12-30
MAINFRAME 8252001 NIM-RESPONSE 2.0	MEDTRONIC XOMED, INC.	2013-12-10
MAINFRAME 8252001 NIM-RESPONSE 2.0	MEDTRONIC XOMED, INC.	2013-11-21
MAINFRAME 8252001 NIM-RESPONSE 2.0	MEDTRONIC XOMED, INC.	2013-10-10
MAINFRAME 8252001 NIM-RESPONSE 2.0	MEDTRONIC XOMED, INC.	2013-10-10
DEVICE 8252200 NIM-RESPONSE 2.0 INTERFAC	MEDTRONIC XOMED, INC	2013-10-04
MAINFRAME 8252001IP RESPONSE 2.0 W/INCRE	MEDTRONIC XOMED, INC.	2013-08-23
INTERFACE 8252800 RESPONSE 2.0 INCREMENT	MEDTRONIC XOMED, INC.	2013-08-06
DEVICE 8252200 NIM-RESPONSE 2.0 INTERFAC	MEDTRONIC XOMED, INC.	2013-06-28