Cleared Traditional

CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE

K082783 · Smiths Medical MD, Inc. · General Hospital
Dec 2008
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K082783 is an FDA 510(k) clearance for the CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE, a Accessories, Pump, Infusion (Class II — Special Controls, product code MRZ), submitted by Smiths Medical MD, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 17, 2008, 85 days after receiving the submission on September 23, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K082783 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2008
Decision Date December 17, 2008
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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