FDA 510(k) Application Details - K180842

Device Classification Name	Warmer, Thermal, Infusion Fluid   More FDA Info for this Device
510(K) Number	K180842
Device Name	Warmer, Thermal, Infusion Fluid
Applicant	MAC Medical Inc. 820 S Mulberry Millstadt, IL 62260 US Other 510(k) Applications for this Company
Contact	Dennis Cooper Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2018
Decision Date	03/05/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review