Cleared Traditional

CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300

K982839 · Sims Deltec, Inc. · General Hospital
Nov 1998
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K982839 is an FDA 510(k) clearance for the CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300, a Pump, Infusion, Pca (Class II — Special Controls, product code MEA), submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on November 2, 1998, 82 days after receiving the submission on August 12, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K982839 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1998
Decision Date November 02, 1998
Days to Decision 82 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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