FDA 510(k) Application Details - K101189

Device Classification Name	Transducer, Blood-Pressure, Extravascular   More FDA Info for this Device
510(K) Number	K101189
Device Name	Transducer, Blood-Pressure, Extravascular
Applicant	REAVILLMED 888 E. BELVIDERE ROAD SUITE 212 GRAYSLAKE, IL 60030 US Other 510(k) Applications for this Company
Contact	MICHELE H VOVOLKA Other 510(k) Applications for this Contact
Regulation Number	870.2850   More FDA Info for this Regulation Number
Classification Product Code	DRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2010
Decision Date	12/22/2010
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