FDA 510(k)

InfuLife

K-Number: K240624 · 2024-11-05

Decision Date2024-11-05

Product CodeMEB

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

InfuLife is the device name listed in this FDA 510(k) record. The listed applicant is First Medical Source, LLC. It received FDA 510(k) clearance on 2024-11-05 under 510(k) number K240624. 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 InfuLife?

InfuLife is a medical device that received FDA 510(k) clearance on 2024-11-05. The listed applicant is First Medical Source, LLC. The 510(k) number is K240624.

When did InfuLife receive FDA 510(k) clearance?

InfuLife received FDA 510(k) clearance on 2024-11-05, under 510(k) number K240624.

Who is the listed applicant for InfuLife?

The FDA 510(k) record lists First Medical Source, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InfuLife?

The FDA product code for InfuLife is MEB.

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.

K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte. , Ltd.K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte. , Ltd.K181360ON-Q* Pump with BolusHalyard Health K151650SMARTez elastomeric infusion pumpEpic Medical Pte. , Ltd.

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.