FDA 510(k) Application Details - K232844

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K232844
Device Name	System, Thermal Regulating
Applicant	BrainCool AB Medicon Village Scheelevagen 2 Lund 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	09/14/2023
Decision Date	10/04/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review