FDA 510(k) Application Details - K180375

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K180375
Device Name	System, Thermal Regulating
Applicant	Brain Cool AB ScheelevΣgen 2 Medicon Village SE-223 81 SE Other 510(k) Applications for this Company
Contact	Martin Waleij 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	02/12/2018
Decision Date	05/18/2018
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