FDA 510(k) Application Details - K111773

Device Classification Name	Oximeter, Reprocessed   More FDA Info for this Device
510(K) Number	K111773
Device Name	Oximeter, Reprocessed
Applicant	RENU MEDICAL, INC. 9800 EVERGREEN WAY EVERETT, WA 98204 US Other 510(k) Applications for this Company
Contact	L BRUCE PIERSON Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	NLF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2011
Decision Date	11/16/2011
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