FDA 510(k) Application Details - K200446

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K200446
Device Name	System, Thermal Regulating
Applicant	STERIS Corporation 5960 Heisley Road Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	Gregory Land 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	02/24/2020
Decision Date	06/13/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review