SMARTez elastomeric infusion pump
K-Number: K151650 · 2016-04-04
ApplicantEpic Medical Pte. , Ltd.
Decision Date2016-04-04
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
SMARTez elastomeric infusion pump is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2016-04-04 under approval number K151650. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SMARTez elastomeric infusion pump?
SMARTez elastomeric infusion pump is a medical device that received FDA 510(k) clearance on 2016-04-04. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K151650.
When was SMARTez elastomeric infusion pump approved by the FDA?
SMARTez elastomeric infusion pump received FDA 510(k) clearance on 2016-04-04, under approval number K151650.
What company makes SMARTez elastomeric infusion pump?
SMARTez elastomeric infusion pump is manufactured by Epic Medical Pte. , Ltd..
What is the FDA product code for SMARTez elastomeric infusion pump?
The FDA product code for SMARTez elastomeric infusion pump is MEB.
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K240517ProSeal Vented Universal Vial Adaptor
K241988ProSeal Closed System Bag Access
Related Devices (Code: MEB)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.