FDA 510(k) Application Details - K210075

Device Classification Name	More FDA Info for this Device
510(K) Number	K210075
Device Name	Vigilant Software Suite û Vigilant Master Med
Applicant	Fresenius Kabi AG Else-Kroner-Str. 1 Bad Homburg 61346 DE Other 510(k) Applications for this Company
Contact	Keith Dunn Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/12/2021
Decision Date	03/01/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review