FDA 510(k) Application Details - K132892

Device Classification Name	Computer, Diagnostic, Pre-Programmed, Single-Function   More FDA Info for this Device
510(K) Number	K132892
Device Name	Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant	BOMED INC 59-440 PILI PL. KAMUELA, HI 96743 US Other 510(k) Applications for this Company
Contact	B. BO SRAMEK, PH.D Other 510(k) Applications for this Contact
Regulation Number	870.1435   More FDA Info for this Regulation Number
Classification Product Code	DXG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/2013
Decision Date	08/01/2014
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