Cleared Traditional

SMARTez elastomeric infusion pump

K151650 · Epic Medical Pte. , Ltd. · General Hospital
Apr 2016
Decision
291d
Days
Class 2
Risk

About This 510(k) Submission

K151650 is an FDA 510(k) clearance for the SMARTez elastomeric infusion pump, a Pump, Infusion, Elastomeric (Class II — Special Controls, product code MEB), submitted by Epic Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on April 4, 2016, 291 days after receiving the submission on June 18, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K151650 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2015
Decision Date April 04, 2016
Days to Decision 291 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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