FDA 510(k) Application Details - K203085

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K203085
Device Name	System, Thermal Regulating
Applicant	Encompass Group, LLC 615 Macon St McDonough, GA 30253 US Other 510(k) Applications for this Company
Contact	Eric Howard Other 510(k) Applications for this Contact
Regulation Number	870.5900   More FDA Info for this Regulation Number
Classification Product Code	DWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/13/2020
Decision Date	11/12/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review