FDA 510(k) Applications for Medical Device Product Code: LEL (Device, Sleep Assessment)

FDA 510(k) Applications for Medical Device Product Code "LEL"
(Device, Sleep Assessment)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K181077	ActiGraph	ActiGraph CentrePoint Insight Watch	05/24/2018
K231532	ActiGraph, LLC	ActiGraph LEAP activity monitor (ActiGraph LEAP)	06/23/2023
K233987	Arbor Medical Innovations, LLC	VERABANDÖ	06/17/2024
K981969	BRAEBON MEDICAL CORP.	ULTIMA BODY POSITION SENSOR	08/20/1998
K040986	CADWELL LABORATORIES, INC.	CADWELL LIMB MOVEMENT MODULE	07/01/2004
K040932	CADWELL LABORATORIES, INC.	EASYNET BODY POSITION MODULE	07/01/2004
K132764	CAMNTECH, LTD	MOTION WATCH AND PRO-DIARY	01/21/2014
K151784	CONDOR INSTRUMENTS LTDA. - EPP	ActTrust	05/25/2016
K961817	KOVEN TECHNOLOGY, INC.	B SMART MODEL 1	07/23/1997
K965079	NEURIM PHARMACEUTICALS, LTD.	SOMNITOR 32K SLEEP ACTIVITY MONITOR	07/10/1997
K233618	Oxehealth Limited	Oxevision Sleep Device	04/03/2024
K243513	PneumoWave, Ltd	DCM (PW-DCM)	04/16/2025
K003499	RESPIRONICS, INC.	REMVIEW SLEEP RECORDER, MODEL 320	02/09/2001
K111514	SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE	SBV2, MULTICHARGER MODEL MC10V2	12/16/2011