FDA 510(k) Application Details - K162523

Device Classification Name	Hyperthermia Monitor   More FDA Info for this Device
510(K) Number	K162523
Device Name	Hyperthermia Monitor
Applicant	BRAIN COOL AB SCHEELEVAGEN 2 MEDICON VILLAGE 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	NZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2016
Decision Date	05/03/2017
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