FDA 510(k) Application Details - K133624

Device Classification Name	Transducer, Blood-Pressure, Extravascular   More FDA Info for this Device
510(K) Number	K133624
Device Name	Transducer, Blood-Pressure, Extravascular
Applicant	MIRADOR BIOMEDICAL 2815 EASTLAKE AVE E SUITE 220 SEATTLE, WA 98102 US Other 510(k) Applications for this Company
Contact	JUSTIN HULVERSHORN 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	11/26/2013
Decision Date	04/18/2014
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