FDA 510(k) Applications for Medical Device Product Code: NOU (Continuous, Ventilator, Home Use)

FDA 510(k) Applications for Medical Device Product Code "NOU"
(Continuous, Ventilator, Home Use)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K233452	Breas Medical AB	Vivo 45 LS	01/13/2025
K193586	Breas Medical AB	Vivo 45 LS	01/27/2021
K160481	BREAS MEDICAL AB	Vivo 60	11/09/2016
K123144	GE HEALTHCARE, BREAS MEDICAL AB	VIVO 50	06/18/2013
K022750	RESPIRONICS CALIFORNIA, INC.	PLV CONTINUUM VENTILATOR, MODEL P1000	11/20/2003
K034032	RESPIRONICS CALIFORNIA, INC.	PLV CONTINUUM VENTILATOR, MODEL P2000	03/16/2004
K021981	VERSAMED LTD.	IVENT 201 PORTABLE VENTILATOR	08/13/2003