Device, Nerve Conduction Velocity Measurement
Regulation 882.1550
0510(k)s in 12 months (27 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in JXE
| Company | 510(k)s | Recalls |
|---|---|---|
| Neurometrix, Inc. | 7 | 0 |
| Chalgren Enterprises, Inc. | 2 | 0 |
| Neurotron Medical | 2 | 0 |
| Bak Electronics | 1 | 0 |
| Biomet, Inc. | 0 | 1 |
| Cadwell Laboratories, Inc. | 1 | 0 |
| Excel Tech. , Ltd. | 1 | 0 |
| Grass Instrument Co. | 1 | 0 |
| Impulse Systems, Inc. | 1 | 0 |
| Insight Medical Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 2025 | K240189 | NM-01/CPT neurometer (NM-01/CPT) Mde Orvosbiológiai Kutató, Fejleszto,, HU | JXE |
| Sep 25, 2019 | K190536 | Mediracer NCS Mediracer OY, FI | JXE |
| Apr 25, 2008 | K070109 | NEUROMETRIX ADVANCE Neurometrix, Inc. | JXE |
| Jul 31, 2006 | K060584 | NC-STAT Neurometrix, Inc. | JXE |
| Feb 7, 2006 | K053058 | XLTEK NEUROPATH, MODEL PK1070 Excel Tech. , Ltd., CA | JXE |
| Oct 27, 2005 | K052904 | VIRTUAL MEDICAL SYSTEMS MODEL VT3000 Scientific Imaging, Inc. | JXE |
| Aug 12, 2004 | K041320 | MODIFICATION TO NC-STAT Neurometrix, Inc. | JXE |
| Jan 17, 2002 | K013459 | MODIFICATION OF NC-STAT Neurometrix, Inc. | JXE |
| Aug 1, 2001 | K012069 | MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT Neurotron Medical, Inc. | JXE |
| Jan 17, 2001 | K003508 | NC-STAT Neurometrix, Inc. | JXE |
| Nov 24, 2000 | K001692 | NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 Neurosoft, Inc. | JXE |
| Jun 27, 2000 | K000565 | MODIFICATION TO NC-STAT Neurometrix, Inc. | JXE |
| Oct 2, 1998 | K982359 | NC-STAT Neurometrix, Inc. | JXE |
| Jul 14, 1997 | K963208 | NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS) Neurotron Medical | JXE |
| Aug 3, 1994 | K935298 | INSTA-NERVE(TM) NERVE CONDUCTION MONITOR Insta Nerve Canada, Inc. | JXE |
| Jul 28, 1994 | K935017 | TD50 ELECTROMYOGRAPH Medelec Intl. Corp., GB | JXE |
| Mar 31, 1994 | K932533 | SMARTSCOPE Insight Medical Corp., CA | JXE |
| Oct 5, 1992 | K923665 | REUSABLE DUAL DISC BAR RECORDING ELECTRODES Chalgren Enterprises, Inc. | JXE |
| Sep 11, 1992 | K921504 | REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS Chalgren Enterprises, Inc. | JXE |
| May 28, 1991 | K904165 | SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT Occupational Preventive Diagnostics, Inc. | JXE |
| Apr 10, 1990 | K900378 | EMG OPTION FOR MICROSHEV 4000 Micro-Shev , Ltd., IL | JXE |
| Jan 17, 1989 | K884663 | IMPULSE EPIDURAL ELECTRODE Impulse Systems, Inc. | JXE |
| Mar 12, 1985 | K843924 | DIGITAL ELECTRONEUROMETER S-100 Neurotron, Inc. | JXE |
| Feb 26, 1985 | K844681 | EMG REPORT GENERATOR Microsystem Controls | JXE |
| Jan 18, 1985 | K844216 | GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR Grass Instrument Co. | JXE |
| Feb 4, 1982 | K820031 | CADWELL 5200 Cadwell Laboratories, Inc. | JXE |
| Oct 5, 1976 | K760689 | NERVEL-NERVE CONDUCTION VELOCITY METER Bak Electronics | JXE |
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