FDA 510(k) Application Details - K063434

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K063434
Device Name	Oximeter
Applicant	RADIOMETER BASEL AG AUSTRASSE 25 BASEL 4051 CH Other 510(k) Applications for this Company
Contact	JEAN-PIERRE PALMA 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	11/13/2006
Decision Date	01/22/2007
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