FDA 510(k) Application Details - DEN160020

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160020
Device Name	CipherOx CRI Tablet
Applicant	Flashback Technologies, Inc. 1215 Spruce Street, Suite 101 Boulder, CO 80302 US Other 510(k) Applications for this Company
Contact	Gordon Van Dusen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PPW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2016
Decision Date	12/21/2016
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review