FDA 510(k) Applications for Medical Device Product Code: OZW ()

FDA 510(k) Applications for Medical Device Product Code "OZW"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K183052	etectRx, Inc.	ID-Cap System	12/06/2019
K223463	Otsuka America Pharmaceutical, Inc.	Otsuka Digital Feedback Device-RW	08/11/2023
DEN120011	PROTEUS BIOMEDICAL, INC.	PROTEUS INGESTION CONFINMATION SYSTEMS	07/10/2012
K150494	PROTEUS DIGITAL HEALTH, INC.	Proteus Digital Health Feedback Device	06/27/2015
K131524	PROTEUS DIGITAL HEALTH, INC.	PROTEUS PATCH INCLUDING INGESTIBLE SENSOR	06/23/2013
K131009	PROTEUS DIGITAL HEALTH, INC.	PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)	05/07/2013
K133263	PROTEUS DIGITAL HEALTH, INC.	PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)	02/07/2014