FDA 510(k) Application Details - K160582

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K160582
Device Name	Oximeter
Applicant	Athena GTX 5900 NW 86th Street, Suite 300 Johnston, IA 50131 US Other 510(k) Applications for this Company
Contact	Sean Mahoney 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	03/01/2016
Decision Date	09/02/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review