FDA 510(k) Application Details - K152749

Device Classification Name	Probe, Blood-Flow, Extravascular   More FDA Info for this Device
510(K) Number	K152749
Device Name	Probe, Blood-Flow, Extravascular
Applicant	Moor Instruments Ltd Millwey Rise Axminster EX13 5HU GB Other 510(k) Applications for this Company
Contact	Stewart Lillington Other 510(k) Applications for this Contact
Regulation Number	870.2120   More FDA Info for this Regulation Number
Classification Product Code	DPT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/2015
Decision Date	05/12/2016
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