Cleared Traditional

CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM

K000842 · Sims Deltec, Inc. · General Hospital
Jun 2000
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K000842 is an FDA 510(k) clearance for the CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 8, 2000, 85 days after receiving the submission on March 15, 2000. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K000842 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2000
Decision Date June 08, 2000
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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