FDA 510(k) Application Details - K151040

Device Classification Name	Transducer, Blood-Pressure, Extravascular   More FDA Info for this Device
510(K) Number	K151040
Device Name	Transducer, Blood-Pressure, Extravascular
Applicant	BIOMETRIX LTD. KIRYAT MADA 4 JERUSALEM 91450 IL Other 510(k) Applications for this Company
Contact	Zoya Lee 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	04/20/2015
Decision Date	09/04/2015
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