FDA 510(k) Application Details - K201298

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K201298
Device Name	Computer, Diagnostic, Programmable
Applicant	Volta Medical 29 Boulevard de Louvain Marseille 13008 FR Other 510(k) Applications for this Company
Contact	ThΘophile Mohr Durdez 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	05/15/2020
Decision Date	09/16/2020
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