FDA 510(k) Application Details - K090422

Device Classification Name	Compressor, Cardiac, External   More FDA Info for this Device
510(K) Number	K090422
Device Name	Compressor, Cardiac, External
Applicant	JOLIFE AB 555 13TH ST. NW WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	HOWARD M HOLSTEIN 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	02/18/2009
Decision Date	06/17/2009
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