FDA 510(k) Application Details - K093881

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K093881
Device Name	Oximeter
Applicant	GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 HELSINKI FIN-00510 FI Other 510(k) Applications for this Company
Contact	TOMMI JOKINIEMI 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	12/18/2009
Decision Date	03/12/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review