FDA 510(k) Application Details - K243205

Device Classification Name	Shunt, Central Nervous System And Components   More FDA Info for this Device
510(K) Number	K243205
Device Name	Shunt, Central Nervous System And Components
Applicant	Phasor Health, LLC 8944 Kirby Drive Houston, TX 77054 US Other 510(k) Applications for this Company
Contact	Ray King Other 510(k) Applications for this Contact
Regulation Number	882.5550   More FDA Info for this Regulation Number
Classification Product Code	JXG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2024
Decision Date	06/03/2025
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