Cleared Traditional

FLO-GARD 6200 VOLUMETRIC INFUSION PUMP

K860162 · Travenol Laboratories, S.A. · General Hospital
Apr 1986
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K860162 is an FDA 510(k) clearance for the FLO-GARD 6200 VOLUMETRIC INFUSION PUMP, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on April 18, 1986, 91 days after receiving the submission on January 17, 1986. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K860162 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 1986
Decision Date April 18, 1986
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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