FDA 510(k) Application Details - K223515

Device Classification Name	More FDA Info for this Device
510(K) Number	K223515
Device Name	MamaLift Plus
Applicant	Curio Digital Therapeutics Inc. 100 Overlook Ctr Fl 2 Princeton, NJ 08540-7814 US Other 510(k) Applications for this Company
Contact	Sidhartha Shankar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2022
Decision Date	04/22/2024
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