FDA 510(k) Application Details - K223463

Device Classification Name	More FDA Info for this Device
510(K) Number	K223463
Device Name	Otsuka Digital Feedback Device-RW
Applicant	Otsuka America Pharmaceutical, Inc. 2440 Research Boulevard Rockville, MD 20850 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	11/16/2022
Decision Date	08/11/2023
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