The following data is part of a premarket notification filed by Deltec Systems, Inc. with the FDA for Cadd-vt, 5300 Ambulatory Infusion Pump W/3050, 50m.
| Device ID | K850183 |
| 510k Number | K850183 |
| Device Name: | CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M |
| Classification | Pump, Infusion |
| Applicant | DELTEC SYSTEMS, INC. 1265 GREY FOX RD. St Paul, MN 55112 |
| Contact | Manuel F Cabezas |
| Correspondent | Manuel F Cabezas DELTEC SYSTEMS, INC. 1265 GREY FOX RD. St Paul, MN 55112 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-18 |
| Decision Date | 1985-03-13 |