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

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

FDA 510(k) Number	Applicant	Device Name	Decision Date
K111549	APNICURE, INC.	ATTUNE SLEEP APNEA SYSTEM	03/30/2012
K122130	APNICURE, INC.	WINX SLEEP THERAPY SYSTEM	10/31/2012
K130538	APNICURE, INC.	WINX SLEEP THERAPY SYSTEM	05/22/2013
K132003	APNICURE, INC.	WINX SLEEP THERAPY SYSTEM	06/13/2014
K193460	Somnice, Inc.	The iNAP One Sleep Therapy System	05/26/2020
K220907	Somnics Inc.	The iNAP One Sleep Therapy System	06/16/2023