FDA 510(k) Application Details - K230866

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K230866
Device Name	System, Thermal Regulating
Applicant	Augustine Temperature Management, LLC 7656 W. 78th St. Minneapolis, MN 55439 US Other 510(k) Applications for this Company
Contact	Garrett Augustine 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	03/29/2023
Decision Date	06/29/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review