FDA 510(k) Application Details - K180482

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K180482
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	ZOLL Medical Corporation 269 & 271 Mill Road Chelmsford, MA 01824-4105 US Other 510(k) Applications for this Company
Contact	Pooja Dalvi Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	MHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2018
Decision Date	11/30/2018
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