FDA 510(k) Application Details - K100815

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K100815
Device Name	Oximeter
Applicant	OXYPULSE ONE MACDONAL CENTER 1 N. MACDONALD SUITE #8 MESA, AZ 85201 US Other 510(k) Applications for this Company
Contact	JAMES A DUNNING 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	03/23/2010
Decision Date	06/16/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review