FDA 510(k) Application Details - K081033

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K081033
Device Name	Oximeter
Applicant	MIR MEDICAL INTL. RESEARCH SRL VIA DEL MAGGIOLINO 125 ROMA 00155 IT Other 510(k) Applications for this Company
Contact	SIMON FOWLER 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	04/11/2008
Decision Date	01/15/2009
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