K240189 is an FDA 510(k) clearance for the NM-01/CPT neurometer (NM-01/CPT). This device is classified as a Device, Nerve Conduction Velocity Measurement (Class II - Special Controls, product code JXE).
Submitted by Mde Orvosbiol?giai Kutat?, Fejleszto, (Budapest, HU). The FDA issued a Cleared decision on March 26, 2025, 427 days after receiving the submission on January 24, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1550.
| 510(k) Number | K240189 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2024 |
| Decision Date | March 26, 2025 |
| Days to Decision | 427 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JXE - Device, Nerve Conduction Velocity Measurement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1550 |