The following data is part of a premarket notification filed by Becton Dickinson Curlin, Llc. with the FDA for Cue Ambulatory Volumetric Infusion Pump.
| Device ID | K981816 |
| 510k Number | K981816 |
| Device Name: | CUE AMBULATORY VOLUMETRIC INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | BECTON DICKINSON CURLIN, LLC. 15751 GRAHAM ST. Huntington Beach, CA 92649 |
| Contact | Charles J Welle |
| Correspondent | Charles J Welle BECTON DICKINSON CURLIN, LLC. 15751 GRAHAM ST. Huntington Beach, CA 92649 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-22 |
| Decision Date | 1998-12-04 |
| Summary: | summary |