FDA 510(k) Application Details - K240189

Device Classification Name	Device, Nerve Conduction Velocity Measurement   More FDA Info for this Device
510(K) Number	K240189
Device Name	Device, Nerve Conduction Velocity Measurement
Applicant	MDE Orvosbiol≤giai Kutat≤, Fejleszto, Gyßrt≤ Korlßtolt FelelossΘgu Tßrsasßg Podmaniczky u. 87 Budapest 1064 HU Other 510(k) Applications for this Company
Contact	Aba Tomjanovich 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	01/24/2024
Decision Date	03/26/2025
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