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FDA 510(k)

SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)

K-Number: K242152 · 2024-10-07

Decision Date2024-10-07
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) 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 2024-10-07 under 510(k) number K242152. 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 (498111, 498121, 498131, 498141)?

SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) is a medical device that received FDA 510(k) clearance on 2024-10-07. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K242152.

When did SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) receive FDA 510(k) clearance?

SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) received FDA 510(k) clearance on 2024-10-07, under 510(k) number K242152.

Who is the listed applicant for SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)?

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 (498111, 498121, 498131, 498141)?

The FDA product code for SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) 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.