FDA 510(k) Application Details - K250749

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K250749
Device Name	Computer, Diagnostic, Programmable
Applicant	PhysCade, Inc. 2100 Geng Road, Suite 210 Palo Alto, CA 94303 US Other 510(k) Applications for this Company
Contact	Raphael Michel 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	03/12/2025
Decision Date	06/04/2025
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