FDA 510(k) Application Details - K232367

Device Classification Name	More FDA Info for this Device
510(K) Number	K232367
Device Name	cmAngio« V1.0
Applicant	CureMetrix, Inc. 402 West Broadway Suite # 400 San Diego, CA 92101 US Other 510(k) Applications for this Company
Contact	Kevin Harris 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	08/08/2023
Decision Date	10/05/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review