FDA 510(k) Application Details - K122810

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K122810
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	THERMOR LTD. 16975 LESLIE ST. NEWMARKET L3Y 9A1 CA Other 510(k) Applications for this Company
Contact	MARK BEATON Other 510(k) Applications for this Contact
Regulation Number	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2012
Decision Date	02/08/2013
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