FDA 510(k) Application Details - K213031

Device Classification Name	System, Hypothermia, Intravenous, Cooling   More FDA Info for this Device
510(K) Number	K213031
Device Name	System, Hypothermia, Intravenous, Cooling
Applicant	Zoll Circulation, Inc. 200 Ringwood Avenue San Jose, CA 95131 US Other 510(k) Applications for this Company
Contact	Elizabeth Haines Other 510(k) Applications for this Contact
Regulation Number	870.5900   More FDA Info for this Regulation Number
Classification Product Code	NCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/21/2021
Decision Date	12/20/2021
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
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