FDA 510(k) Application Details - K002957

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K002957
Device Name	Oximeter
Applicant	GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. MILWAUKEE, WI 53223 US Other 510(k) Applications for this Company
Contact	DAVID WAHLIG 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	09/22/2000
Decision Date	10/18/2000
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