FDA 510(k) Application Details - K251088

Device Classification Name	More FDA Info for this Device
510(K) Number	K251088
Device Name	Otsuka Digital Feedback Device
Applicant	Otsuka America Pharmaceutical, Inc. 3956 Point Eden Way Hayward, CA 94545 US Other 510(k) Applications for this Company
Contact	Nancy Teague Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/09/2025
Decision Date	06/30/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review