FDA 510(k) Application Details - DEN140016

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN140016
Device Name	STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
Applicant	DEXCOM, INC. 6340 SEQUENCE DR SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	ANDREW BALO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2014
Decision Date	08/19/2014
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review