FDA 510(k) Application Details - K983684

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K983684
Device Name	Oximeter
Applicant	DATEX-OHMEDA, INC. 1315 WEST CENTURY DR. LOUISVILLE, CO 80027 US Other 510(k) Applications for this Company
Contact	TOM KROENKE 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	10/20/1998
Decision Date	11/06/1998
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