FDA 510(k) Application Details - K233903

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K233903
Device Name	Neurological Stereotaxic Instrument
Applicant	Zeta Surgical Inc 115 Kingston St Floor 2 Boston, MA 02111 US Other 510(k) Applications for this Company
Contact	Roman Stolyarov Other 510(k) Applications for this Contact
Regulation Number	882.4560   More FDA Info for this Regulation Number
Classification Product Code	HAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2023
Decision Date	01/10/2024
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