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FDA 510(k)

Ecomed Disposable Administration Sets

K-Number: K234129 · 2024-09-20

ApplicantEcomed Solutions, LLC
Decision Date2024-09-20
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Ecomed Disposable Administration Sets is the device name listed in this FDA 510(k) record. The listed applicant is Ecomed Solutions, LLC. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K234129. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ecomed Disposable Administration Sets?

Ecomed Disposable Administration Sets is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Ecomed Solutions, LLC. The 510(k) number is K234129.

When did Ecomed Disposable Administration Sets receive FDA 510(k) clearance?

Ecomed Disposable Administration Sets received FDA 510(k) clearance on 2024-09-20, under 510(k) number K234129.

Who is the listed applicant for Ecomed Disposable Administration Sets?

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

What is the FDA product code for Ecomed Disposable Administration Sets?

The FDA product code for Ecomed Disposable Administration Sets is FPA.

Other records listing Ecomed Solutions, LLC 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.

K162088Ecomed Disposable Angiographic Syringes

Related Devices (Code: FPA)

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.

K261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)K251814EZ™ IV Administration SetEpic 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.

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