FDA Product Code
FDA Product Code JXE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1550
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240189 | NM-01/CPT neurometer (NM-01/CPT) | Mde Orvosbiológiai Kutató, Fejleszto, | 2025-03-26 | Traditional | PDF ↗ |
| K190536 | Mediracer NCS | Mediracer OY | 2019-09-25 | Traditional | PDF ↗ |
| K070109 | NEUROMETRIX ADVANCE | Neurometrix, Inc. | 2008-04-25 | Traditional | PDF ↗ |
| K060584 | NC-STAT | Neurometrix, Inc. | 2006-07-31 | Traditional | PDF ↗ |
| K053058 | XLTEK NEUROPATH, MODEL PK1070 | Excel Tech. , Ltd. | 2006-02-07 | Traditional | PDF ↗ |
| K052904 | VIRTUAL MEDICAL SYSTEMS MODEL VT3000 | Scientific Imaging, Inc. | 2005-10-27 | Traditional | PDF ↗ |
| K041320 | MODIFICATION TO NC-STAT | Neurometrix, Inc. | 2004-08-12 | Traditional | PDF ↗ |
| K013459 | MODIFICATION OF NC-STAT | Neurometrix, Inc. | 2002-01-17 | Traditional | PDF ↗ |
| K012069 | MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT | Neurotron Medical, Inc. | 2001-08-01 | Special | PDF ↗ |
| K003508 | NC-STAT | Neurometrix, Inc. | 2001-01-17 | Traditional | PDF ↗ |
| K001692 | NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 | Neurosoft, Inc. | 2000-11-24 | Traditional | PDF ↗ |
| K000565 | MODIFICATION TO NC-STAT | Neurometrix, Inc. | 2000-06-27 | Traditional | PDF ↗ |
| K982359 | NC-STAT | Neurometrix, Inc. | 1998-10-02 | Traditional | PDF ↗ |
| K963208 | NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS) | Neurotron Medical | 1997-07-14 | Traditional | PDF ↗ |
| K935298 | INSTA-NERVE(TM) NERVE CONDUCTION MONITOR | Insta Nerve Canada, Inc. | 1994-08-03 | Traditional | PDF ↗ |
| K935017 | TD50 ELECTROMYOGRAPH | Medelec Intl. Corp. | 1994-07-28 | Traditional | PDF ↗ |
| K932533 | SMARTSCOPE | Insight Medical Corp. | 1994-03-31 | Traditional | PDF ↗ |
| K923665 | REUSABLE DUAL DISC BAR RECORDING ELECTRODES | Chalgren Enterprises, Inc. | 1992-10-05 | Traditional | PDF ↗ |
| K921504 | REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS | Chalgren Enterprises, Inc. | 1992-09-11 | Traditional | PDF ↗ |
| K904165 | SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT | Occupational Preventive Diagnostics, Inc. | 1991-05-28 | Traditional | PDF ↗ |
| K900378 | EMG OPTION FOR MICROSHEV 4000 | Micro-Shev , Ltd. | 1990-04-10 | Traditional | PDF ↗ |
| K884663 | IMPULSE EPIDURAL ELECTRODE | Impulse Systems, Inc. | 1989-01-17 | Traditional | PDF ↗ |
| K843924 | DIGITAL ELECTRONEUROMETER S-100 | Neurotron, Inc. | 1985-03-12 | Traditional | PDF ↗ |
| K844681 | EMG REPORT GENERATOR | Microsystem Controls | 1985-02-26 | Traditional | PDF ↗ |
| K844216 | GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR | Grass Instrument Co. | 1985-01-18 | Traditional | PDF ↗ |
| K820031 | CADWELL 5200 | Cadwell Laboratories, Inc. | 1982-02-04 | Traditional | PDF ↗ |
| K760689 | NERVEL-NERVE CONDUCTION VELOCITY METER | Bak Electronics | 1976-10-05 | Traditional | PDF ↗ |
Product code JXE · Class II · Neurology. Data: openFDA.