FDA 510(k) Application Details - K112465

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K112465
Device Name	Oximeter
Applicant	ADVANCED INSTRUMENTS, INC. 601 WEST 20 ST HIALEAH, FL 33010 US Other 510(k) Applications for this Company
Contact	JORGE MILLAN Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	DQA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2011
Decision Date	09/14/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review