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 Pump, Infusion
510(k) Number K211218
Device Name BD Alaris System with Guardrails Suite MX v12.1.2
Applicant
CareFusion 303 Inc.
10020 Pacific Mesa Blvd.
San Diego,  CA  92121
Applicant Contact Laurie Cartwright
Correspondent
CareFusion 303 Inc.
10020 Pacific Mesa Blvd.
San Diego,  CA  92121
Correspondent Contact Laurie Cartwright
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Codes
CCK   MEA   PHC  
Date Received04/23/2021
Decision Date 07/21/2023
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
Recalls CDRH Recalls
-
-