JXE — Device, Nerve Conduction Velocity Measurement Class II
FDA Device Classification
Classification Details
- Product Code
- JXE
- Device Class
- Class II
- Regulation Number
- 882.1550
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K240189 | mde orvosbiológiai kutató, fejleszto | NM-01/CPT neurometer (NM-01/CPT) | March 26, 2025 |
| K190536 | mediracer | Mediracer NCS | September 25, 2019 |
| K070109 | neurometrix | NEUROMETRIX ADVANCE | April 25, 2008 |
| K060584 | neurometrix | NC-STAT | July 31, 2006 |
| K053058 | excel tech. | XLTEK NEUROPATH, MODEL PK1070 | February 7, 2006 |
| K052904 | scientific imaging | VIRTUAL MEDICAL SYSTEMS MODEL VT3000 | October 27, 2005 |
| K041320 | neurometrix | MODIFICATION TO NC-STAT | August 12, 2004 |
| K013459 | neurometrix | MODIFICATION OF NC-STAT | January 17, 2002 |
| K012069 | neurotron medical | MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT | August 1, 2001 |
| K003508 | neurometrix | NC-STAT | January 17, 2001 |
| K001692 | neurosoft | NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 | November 24, 2000 |
| K000565 | neurometrix | MODIFICATION TO NC-STAT | June 27, 2000 |
| K982359 | neurometrix | NC-STAT | October 2, 1998 |
| K963208 | neurotron medical | NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS) | July 14, 1997 |
| K935298 | insta nerve canada | INSTA-NERVE(TM) NERVE CONDUCTION MONITOR | August 3, 1994 |
| K935017 | medelec intl | TD50 ELECTROMYOGRAPH | July 28, 1994 |
| K932533 | insight medical | SMARTSCOPE | March 31, 1994 |
| K923665 | chalgren enterprises | REUSABLE DUAL DISC BAR RECORDING ELECTRODES | October 5, 1992 |
| K921504 | chalgren enterprises | REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS | September 11, 1992 |
| K904165 | occupational preventive diagnostics | SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT | May 28, 1991 |