The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Flo-gard 4000 Volumetric Infusion Controller.
| Device ID | K854863 |
| 510k Number | K854863 |
| Device Name: | FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER |
| Classification | Controller, Infusion, Intravascular, Electronic |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Contact | Brain Stembal |
| Correspondent | Brain Stembal TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Product Code | LDR |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-05 |
| Decision Date | 1986-02-12 |