FDA 510(k) Application Details - K231182

Device Classification Name	Hyperthermia Monitor   More FDA Info for this Device
510(K) Number	K231182
Device Name	Hyperthermia Monitor
Applicant	ZOLL Circulation, Inc 2000 Ringwood Avenue San Jose, CA 95131 US Other 510(k) Applications for this Company
Contact	Sean Manning 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	04/26/2023
Decision Date	11/03/2023
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