FDA 510(k) Application Details - K172458

Device Classification Name	Transducer, Blood-Pressure, Extravascular   More FDA Info for this Device
510(K) Number	K172458
Device Name	Transducer, Blood-Pressure, Extravascular
Applicant	Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 US Other 510(k) Applications for this Company
Contact	Mikael Evans 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	08/14/2017
Decision Date	11/09/2017
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