FDA 510(k) Application Details - K233160

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K233160
Device Name	Computer, Diagnostic, Programmable
Applicant	Anumana, Inc 1 Main St. East Arcade , 4th Floor Cambridge, MA 01242 US Other 510(k) Applications for this Company
Contact	Suzanne Goodman Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2023
Decision Date	11/25/2023
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