FDA 510(k) Application Details - K101518

Device Classification Name	Transducer, Blood-Pressure, Extravascular   More FDA Info for this Device
510(K) Number	K101518
Device Name	Transducer, Blood-Pressure, Extravascular
Applicant	MIRADOR BIOMEDICAL, INC. 2815 WASTLAKE AVENUE SUITE 300 SEATTLE, WA 98102 US Other 510(k) Applications for this Company
Contact	JUSTIN HULVERSHORN MD, PHD 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	06/02/2010
Decision Date	10/13/2010
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