The following data is part of a premarket notification filed by Deka Research & Development with the FDA for Volumetric Infusion Controller.
| Device ID | K153760 |
| 510k Number | K153760 |
| Device Name: | Volumetric Infusion Controller |
| Classification | Controller, Infusion, Intravascular, Electronic |
| Applicant | DEKA RESEARCH & DEVELOPMENT 340 COMMERCIAL ST. Manchester, NH 03101 |
| Contact | Julie Perkins |
| Correspondent | Roger Leroux DEKA RESEARCH & DEVELOPMENT 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 | 2015-12-30 |
| Decision Date | 2016-10-03 |
| Summary: | summary |