FDA 510(k) Application Details - K103802

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K103802
Device Name	Oximeter
Applicant	GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 HELSINKI FIN-00510 FI Other 510(k) Applications for this Company
Contact	TATJA PASANEN 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	12/28/2010
Decision Date	08/02/2011
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