FDA 510(k) Application Details - K092219

Device Classification Name	Computer, Diagnostic, Pre-Programmed, Single-Function   More FDA Info for this Device
510(K) Number	K092219
Device Name	Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant	APPLIED PHYSIOLOGY PTY LTD. 13605 W. 7TH AVE. GOLDEN, CO 80401 US Other 510(k) Applications for this Company
Contact	ROBERT N CLARK 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	07/22/2009
Decision Date	05/12/2010
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