FDA 510(k) Application Details - K124049

Device Classification Name	Probe, Blood-Flow, Extravascular   More FDA Info for this Device
510(K) Number	K124049
Device Name	Probe, Blood-Flow, Extravascular
Applicant	Spectral MD, Inc 1201 RICHARDSON DRIVE, SUITE 280 RICHARDSON, TX 75080 US Other 510(k) Applications for this Company
Contact	DIANE RUTHERFORD 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	12/31/2012
Decision Date	04/18/2013
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