The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for 360 Infuser.
| Device ID | K844719 |
| 510k Number | K844719 |
| Device Name: | 360 INFUSER |
| Classification | Pump, Infusion |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Contact | Russell J Arnsberge |
| Correspondent | Russell J Arnsberge BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-04 |
| Decision Date | 1985-01-28 |