FDA 510(k) Application Details - K220008

Device Classification Name	System, Hypothermia, Intravenous, Cooling   More FDA Info for this Device
510(K) Number	K220008
Device Name	System, Hypothermia, Intravenous, Cooling
Applicant	ZOLL Circulation, Inc 2000 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	01/04/2022
Decision Date	06/02/2022
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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