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

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

FDA 510(k) Number	Applicant	Device Name	Decision Date
K180244	Advanced Cooling Therapy, Inc. d/b/a Attune Medical	EnsoETM	02/28/2018
K180742	Advanced Cooling Therapy, Inc. d/b/a Attune Medical	EnsoETM	05/17/2018
DEN140018	ADVANCED COOLING THERAPY, LLC	ESOPHAGEAL COOLING DEVICE	06/23/2015
K152450	ADVANCED COOLING THERAPY, LLC	Esophageal Cooling Device	01/15/2016
K170009	ADVANCED COOLING THERAPY, LLC	Esophageal Cooling Device	03/30/2017
K172029	Attune Medical	EnsoETM	01/05/2018
K172493	Attune Medical	EnsoETM	10/17/2017