FDA 510(k) Application Details - K190939

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K190939
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	ZOLL Manufacturing Corporation 121 Gamma Drive Pittsburgh, PA 15238 US Other 510(k) Applications for this Company
Contact	Zachary Nelson 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	04/10/2019
Decision Date	12/19/2019
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