FDA 510(k) Application Details - K190536

Device Classification Name	Device, Nerve Conduction Velocity Measurement   More FDA Info for this Device
510(K) Number	K190536
Device Name	Device, Nerve Conduction Velocity Measurement
Applicant	Mediracer Oy Rantakatu 4 Oulu 90100 FI Other 510(k) Applications for this Company
Contact	Lassi Laitinen Other 510(k) Applications for this Contact
Regulation Number	882.1550   More FDA Info for this Regulation Number
Classification Product Code	JXE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2019
Decision Date	09/25/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review