FDA 510(k)

eZSURE™ Empty Fluid Container with ProSeal™ Injection Site

Número K: K241442 · 2024-06-21

Data da decisão2024-06-21

Código do produtoKPE

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

eZSURE™ Empty Fluid Container with ProSeal™ Injection Site 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 2024-06-21 under 510(k) number K241442. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the eZSURE™ Empty Fluid Container with ProSeal™ Injection Site?

eZSURE™ Empty Fluid Container with ProSeal™ Injection Site is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K241442.

When did eZSURE™ Empty Fluid Container with ProSeal™ Injection Site receive FDA 510(k) clearance?

eZSURE™ Empty Fluid Container with ProSeal™ Injection Site received FDA 510(k) clearance on 2024-06-21, under 510(k) number K241442.

Who is the listed applicant for eZSURE™ Empty Fluid Container with ProSeal™ Injection Site?

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 eZSURE™ Empty Fluid Container with ProSeal™ Injection Site?

The FDA product code for eZSURE™ Empty Fluid Container with ProSeal™ Injection Site is KPE.

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Outros registros que listam Epic Medical Pte. , Ltd. como candidato(a)

K252987ADRx® Admixture Device K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)K251722ProSeal™ Transfer Injector (421120, 421130, 421140)K251814EZ™ IV Administration Set K252094eZSURE™ Empty Fluid Container K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

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Dispositivos Relacionados (Código: KPE)

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AG K252094eZSURE™ 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.K223674eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)Epic Medical Pte. , Ltd.

Fonte oficial

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