FDA 510(k) Application Details - K181671

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K181671
Device Name	System, Thermal Regulating
Applicant	Care Essentials Pty Ltd 25 Slevin St North Geelong 3215 AU Other 510(k) Applications for this Company
Contact	Abhay Sinha 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	06/25/2018
Decision Date	05/02/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review