FDA 510(k) Application Details - K242726

Device Classification Name	Nystagmograph   More FDA Info for this Device
510(K) Number	K242726
Device Name	Nystagmograph
Applicant	Inventis S.r.l. Corso Stati Uniti 1/3 Padova 35127 IT Other 510(k) Applications for this Company
Contact	Elena Tormen 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	09/10/2024
Decision Date	01/03/2025
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