Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Infusion Safety Management Software
510(k) Number K210075
Device Name Vigilant Software Suite – Vigilant Master Med
Applicant
Fresenius Kabi AG
Else-Kroner-Str. 1
Bad Homburg,  DE 61346
Applicant Contact Keith Dunn
Correspondent
Fresenius Kabi, LLC, USA
3 Corporate Dr.
Suite 300
Lake Zurich,  IL  60047
Correspondent Contact Keith Dunn
Regulation Number880.5725
Classification Product Code
PHC  
Date Received01/12/2021
Decision Date 03/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-