FDA 510(k) Application Details - K082191

Device Classification Name	Sensor, Pressure, Aneurysm, Implantable   More FDA Info for this Device
510(K) Number	K082191
Device Name	Sensor, Pressure, Aneurysm, Implantable
Applicant	CARDIOMEMS INC 387 TECHNOLOGY CIRCLE, NW SUITE 500 ATLANTA, GA 30313 US Other 510(k) Applications for this Company
Contact	GRACE POWERS Other 510(k) Applications for this Contact
Regulation Number	870.2855   More FDA Info for this Regulation Number
Classification Product Code	NQH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2008
Decision Date	08/19/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review