FDA 510(k) Application Details - K122996

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K122996
Device Name	Oximeter
Applicant	XHALE 701 HEBRON AVENUE GLASTONBURY, CT 06033 US Other 510(k) Applications for this Company
Contact	DAVID RICH 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	09/27/2012
Decision Date	04/10/2013
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