FDA 510(k) Application Details - K112998

Device Classification Name	Compressor, Cardiac, External   More FDA Info for this Device
510(K) Number	K112998
Device Name	Compressor, Cardiac, External
Applicant	ZOLL CIRCULATION 2000 Ringwood Ave San Jose, CA 95131 US Other 510(k) Applications for this Company
Contact	SAM NANAVATI Other 510(k) Applications for this Contact
Regulation Number	870.5200   More FDA Info for this Regulation Number
Classification Product Code	DRM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/2011
Decision Date	03/15/2012
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