FDA 510(k) Application Details - K242198

Device Classification Name	Nystagmograph   More FDA Info for this Device
510(K) Number	K242198
Device Name	Nystagmograph
Applicant	Natus Medical Denmark Aps Hoerskaetten 9 Taastrup DK-2630 DK Other 510(k) Applications for this Company
Contact	Therese Coffey Other 510(k) Applications for this Contact
Regulation Number	882.1460   More FDA Info for this Regulation Number
Classification Product Code	GWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2024
Decision Date	02/14/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review