FDA 510(k) Application Details - K240003

Device Classification Name	Analyzer,Medical Image   More FDA Info for this Device
510(K) Number	K240003
Device Name	Analyzer,Medical Image
Applicant	Velmeni Inc. 333 West Maude Avenue Suite 207 Sunnyvale, CA 94085 US Other 510(k) Applications for this Company
Contact	Mini Suri Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2024
Decision Date	08/30/2024
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