The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Flo-gard 6200 Volumetric Infusion Pump.
Device ID | K860162 |
510k Number | K860162 |
Device Name: | FLO-GARD 6200 VOLUMETRIC INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Contact | Brian Stembal |
Correspondent | Brian Stembal TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-17 |
Decision Date | 1986-04-18 |