FDA 510(k) Application Details - K083719

Device Classification Name	Oximeter, Reprocessed   More FDA Info for this Device
510(K) Number	K083719
Device Name	Oximeter, Reprocessed
Applicant	MASIMO CORPORATION 40 PARKER IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	MARGUERITE THOMLINSON 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	12/15/2008
Decision Date	07/30/2009
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