FDA 510(k) Application Details - K173929

Device Classification Name	More FDA Info for this Device
510(K) Number	K173929
Device Name	CipherOx CRI M1
Applicant	Flashback Technologies, Inc. 80 Health Park Drive, Suite 20 Louisville, CO 80027 US Other 510(k) Applications for this Company
Contact	Gregory Z. Grudic 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	12/26/2017
Decision Date	07/24/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review