Cleared Traditional

AMBULATORY INFUSION PUMP, MODEL AS30C

K863864 · Travenol Laboratories, S.A. · General Hospital
Feb 1987
Decision
124d
Days
Class 2
Risk

About This 510(k) Submission

K863864 is an FDA 510(k) clearance for the AMBULATORY INFUSION PUMP, MODEL AS30C, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Travenol Laboratories, S.A. (Hooksett, US). The FDA issued a Cleared decision on February 4, 1987, 124 days after receiving the submission on October 3, 1986. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K863864 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 1986
Decision Date February 04, 1987
Days to Decision 124 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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