The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Flo-gard 8000 Computer Control Infusi.
Device ID | K834154 |
510k Number | K834154 |
Device Name: | FLO-GARD 8000 COMPUTER CONTROL INFUSI |
Classification | Controller, Infusion, Intravascular, Electronic |
Applicant | TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LDR |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-02 |
Decision Date | 1984-01-25 |