FDA 510(k) Application Details - K123446

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K123446
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	United States GTM Medical Devices, Inc. 5850 Oberlin Drive #240 San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Kenneth K Kleinhenz 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	11/08/2012
Decision Date	12/07/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review