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FDA 510(k)

Empty EVA Bag

K-Number: K193528 · 2020-07-22

ApplicantHaemotronic S.P.A.
Decision Date2020-07-22
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Empty EVA Bag is the device name listed in this FDA 510(k) record. The listed applicant is Haemotronic S.P.A.. It received FDA 510(k) clearance on 2020-07-22 under 510(k) number K193528. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Empty EVA Bag?

Empty EVA Bag is a medical device that received FDA 510(k) clearance on 2020-07-22. The listed applicant is Haemotronic S.P.A.. The 510(k) number is K193528.

When did Empty EVA Bag receive FDA 510(k) clearance?

Empty EVA Bag received FDA 510(k) clearance on 2020-07-22, under 510(k) number K193528.

Who is the listed applicant for Empty EVA Bag?

The FDA 510(k) record lists Haemotronic S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Empty EVA Bag?

The FDA product code for Empty EVA Bag is KPE.

Other records listing Haemotronic S.P.A. 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.

K210749Empty EVA Bag

Related Devices (Code: KPE)

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.

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AGK252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container SolutionTechnoflex Sas.K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic 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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