The following data is part of a premarket notification filed by Deka Research & Development Corp. with the FDA for Dk*300 Volumetric Infusion Controller.
| Device ID | K843254 |
| 510k Number | K843254 |
| Device Name: | DK*300 VOLUMETRIC INFUSION CONTROLLER |
| Classification | Controller, Infusion, Intravascular, Electronic |
| Applicant | DEKA RESEARCH & DEVELOPMENT CORP. 340 COMMERCIAL ST. Manchester, NH 03101 |
| Contact | Stephen W Sagon |
| Correspondent | Stephen W Sagon DEKA RESEARCH & DEVELOPMENT CORP. 340 COMMERCIAL ST. Manchester, NH 03101 |
| Product Code | LDR |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-20 |
| Decision Date | 1984-10-11 |