FDA 510(k) Application Details - K040831

Device Classification Name	Oximeter, Ear   More FDA Info for this Device
510(K) Number	K040831
Device Name	Oximeter, Ear
Applicant	DATEX-OHMEDA, INC. 1315 WEST CENTURY DR. LOUISVILLE, CO 80027 US Other 510(k) Applications for this Company
Contact	SCOTT LIGHT Other 510(k) Applications for this Contact
Regulation Number	870.2710   More FDA Info for this Regulation Number
Classification Product Code	DPZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2004
Decision Date	09/02/2004
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