FDA 510(k) Application Details - K053398

Device Classification Name	Clamp, Vascular   More FDA Info for this Device
510(K) Number	K053398
Device Name	Clamp, Vascular
Applicant	SEMLER TECHNOLOGIES, INC. DBA 2326 NW EVERETT ST. PORTLAND, OR 97027 US Other 510(k) Applications for this Company
Contact	HERBERT J SEMLER Other 510(k) Applications for this Contact
Regulation Number	870.4450   More FDA Info for this Regulation Number
Classification Product Code	DXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2005
Decision Date	03/10/2006
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