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 K182092
Device Name BD Intelliport System
Applicant
Becton, Dickinson, and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Applicant Contact Rahul Ram
Correspondent
Becton, Dickinson, and Company
1 Becton Drive
Franklin Lakes,  NJ  07417
Correspondent Contact Rahul Ram
Regulation Number880.5725
Classification Product Code
PHC  
Subsequent Product Code
FPA  
Date Received08/03/2018
Decision Date 04/30/2019
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
-
-