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 |