FDA 510(k) Application Details - K042675

Device Classification Name	Oximeter, Ear   More FDA Info for this Device
510(K) Number	K042675
Device Name	Oximeter, Ear
Applicant	ELEKON INDUSTRIES U.S.A., INC. 2300 MCDERMOTT RD. #200-207 PLANO, TX 75025 US Other 510(k) Applications for this Company
Contact	KRISTA OAKES 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	09/29/2004
Decision Date	12/06/2004
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