The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Travenol Flo-gard 500 Iv Monitor.
| Device ID | K850710 |
| 510k Number | K850710 |
| Device Name: | TRAVENOL FLO-GARD 500 IV MONITOR |
| Classification | Monitor, Electric For Gravity Flow Infusion Systems |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Contact | Brian Stembal |
| Correspondent | Brian Stembal TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Product Code | FLN |
| CFR Regulation Number | 880.2420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-22 |
| Decision Date | 1985-04-04 |