The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Flo-gard 8100 Infusion Pump.
| Device ID | K833958 |
| 510k Number | K833958 |
| Device Name: | FLO-GARD 8100 INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-16 |
| Decision Date | 1983-12-29 |