FDA 510(k) Application Details - K182093

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K182093
Device Name	Electrocardiograph
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	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/03/2018
Decision Date	01/28/2019
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