FDA 510(k) Application Details - K233751

Device Classification Name	More FDA Info for this Device
510(K) Number	K233751
Device Name	Milieve (YPS-301BD)
Applicant	Soterix Medical, Inc. 1480 U.S. Highway 9 North Suite 204 Woodbridge, NJ 07095 US Other 510(k) Applications for this Company
Contact	Danielle Dadona Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2023
Decision Date	06/03/2024
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