IKN — Electromyograph, Diagnostic Class II
FDA Device Classification
Classification Details
- Product Code
- IKN
- Device Class
- Class II
- Regulation Number
- 890.1375
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K172743 | natus neurology incorporated | Natus VikingQuest | December 19, 2017 |
| K163150 | dorsavi | ViMove2 | July 14, 2017 |
| K162383 | cadwell industries | Cadwell Sierra Summit, Cadwell Sierra Ascent | March 1, 2017 |
| K142494 | dorsavi | ViMove | May 28, 2015 |
| K131094 | dorsa vi pty | VIMOVE | July 11, 2014 |
| K123902 | oktx | PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) | September 13, 2013 |
| K123399 | precision biometrics | MYOVISION 3.0 WIREFREE SYSTEM | August 1, 2013 |
| K113074 | medical technologies | CMAP PRO | February 2, 2012 |
| K102610 | teleemg, llc usa | FOCUS EMG DEVICE | March 4, 2011 |
| K110048 | spinematrix | CERSR ELECTROMYOGRAPHY SYSTEM | January 26, 2011 |
| K083679 | uroval | UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 | September 11, 2009 |
| K073415 | eb neuro | NEMUS SYSTEM; NEMUS PC PERIPHERAL | May 23, 2008 |
| K063447 | fasstech | INSIGHT DISCOVERY | August 16, 2007 |
| K052112 | excel tech. | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 | October 28, 2005 |
| K031995 | medical technologies unlimited | COMPREHENSIVE NEUROMUSCULAR PROFILER | January 7, 2004 |
| K033452 | fasstech | CWAS 1000 | November 28, 2003 |
| K023209 | fasstech | INSIGHT MILLENNIUM III | October 10, 2003 |
| K024316 | medtronic xomed | NIM-PRS | January 6, 2003 |
| K023147 | bortec biomedical | ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & | December 12, 2002 |
| K022719 | maryrose cusimano, ph.d./phil reaston | PHYSICAL MONITORING REGISTRATION UNIT | November 13, 2002 |