Cleared Traditional

FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD

K870801 · Travenol Laboratories, S.A. · General Hospital
Sep 1987
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K870801 is an FDA 510(k) clearance for the FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on September 4, 1987, 189 days after receiving the submission on February 27, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K870801 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1987
Decision Date September 04, 1987
Days to Decision 189 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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