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FDA 510(k)

SMARTez elastomeric infusion pump

K-Number: K151650 · 2016-04-04

Decision Date2016-04-04
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SMARTez elastomeric infusion pump is the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2016-04-04 under 510(k) 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. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K151650.

When did SMARTez elastomeric infusion pump receive FDA 510(k) clearance?

SMARTez elastomeric infusion pump received FDA 510(k) clearance on 2016-04-04, under 510(k) number K151650.

Who is the listed applicant for SMARTez elastomeric infusion pump?

The FDA 510(k) record lists Epic Medical Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTez elastomeric infusion pump?

The FDA product code for SMARTez elastomeric infusion pump is MEB.

Other records listing Epic Medical Pte. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 22 devices →

Related Devices (Code: MEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.