The following data is part of a premarket notification filed by Mediracer Oy with the FDA for Mediracer Ncs.
| Device ID | K190536 |
| 510k Number | K190536 |
| Device Name: | Mediracer NCS |
| Classification | Device, Nerve Conduction Velocity Measurement |
| Applicant | Mediracer Oy Rantakatu 4 Oulu, FI 90100 |
| Contact | Lassi Laitinen |
| Correspondent | Lassi Laitinen Mediracer Oy Rantakatu 4 Oulu, FI 90100 |
| Product Code | JXE |
| CFR Regulation Number | 882.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-04 |
| Decision Date | 2019-09-25 |
| Summary: | summary |