FDA 510(k) Application Details - K143216

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K143216
Device Name	Oximeter
Applicant	Xhale, Inc. 3630 SW 47th Ave, Suite 100 Gainesville, FL 32608 US Other 510(k) Applications for this Company
Contact	Jeffrey Hoebelheinrich 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	11/10/2014
Decision Date	03/17/2015
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