The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Flo-gard 4000 Volumetric Infusion.
Device ID | K840644 |
510k Number | K840644 |
Device Name: | FLO-GARD 4000 VOLUMETRIC INFUSION |
Classification | Controller, Infusion, Intravascular, Electronic |
Applicant | TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LDR |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-15 |
Decision Date | 1984-03-23 |