FDA 510(k) Application Details - K213255

Device Classification Name	More FDA Info for this Device
510(K) Number	K213255
Device Name	CipherOx CRI Tablet
Applicant	Flashback Technologies, Inc. 208 Lenox Ave #307 Westfield, NJ 07090 US Other 510(k) Applications for this Company
Contact	John Jedziniak 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	09/30/2021
Decision Date	06/17/2022
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