FDA 510(k) Application Details - K222676

Device Classification Name	More FDA Info for this Device
510(K) Number	K222676
Device Name	Ceevra Reveal 3
Applicant	Ceevra, Inc. 149 New Montgomery St, 4th Fl. San Francisco, CA 94105 US Other 510(k) Applications for this Company
Contact	Ken Koster Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2022
Decision Date	04/25/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review