FDA 510(k) Application Details - K250601

Device Classification Name	Electrode, Depth   More FDA Info for this Device
510(K) Number	K250601
Device Name	Electrode, Depth
Applicant	Alpha Omega Engineering Ltd. Hamerkava St.6, Tsiporit Industrial Zone P.O. Box 810 Nof HaGalil (Nazareth Illit) 1789062 IL Other 510(k) Applications for this Company
Contact	Efrat Shamgar Other 510(k) Applications for this Contact
Regulation Number	882.1330   More FDA Info for this Regulation Number
Classification Product Code	GZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2025
Decision Date	03/30/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review