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 |