K190536 is an FDA 510(k) clearance for the Mediracer NCS. This device is classified as a Device, Nerve Conduction Velocity Measurement (Class II - Special Controls, product code JXE).
Submitted by Mediracer OY (Oulu, FI). The FDA issued a Cleared decision on September 25, 2019, 205 days after receiving the submission on March 4, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1550.
| 510(k) Number | K190536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2019 |
| Decision Date | September 25, 2019 |
| Days to Decision | 205 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 |