The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Becton Dickinson Intelliport System.
Device ID | K141474 |
510k Number | K141474 |
Device Name: | BECTON DICKINSON INTELLIPORT SYSTEM |
Classification | Infusion Safety Management Software |
Applicant | BECTON DICKINSON & CO. 11665 AVENA PLACE, SUITE 203 San Diego, CA 92128 |
Contact | Daniel Olivier |
Correspondent | Daniel Olivier BECTON DICKINSON & CO. 11665 AVENA PLACE, SUITE 203 San Diego, CA 92128 |
Product Code | PHC |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-03 |
Decision Date | 2014-12-18 |
Summary: | summary |