FDA 510(k) Application Details - K024215

Device Classification Name	Compressor, Cardiac, External   More FDA Info for this Device
510(K) Number	K024215
Device Name	Compressor, Cardiac, External
Applicant	ENERTRON ENGINEERING CO. NO. 58, FU-CHIUN ST. HSIN-CHU CITY 300 TW Other 510(k) Applications for this Company
Contact	Ke-Min Jen 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	12/20/2002
Decision Date	05/14/2004
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