FDA 510(k)

eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)

K-번호: K223674 · 2023-09-01

결정일2023-09-01

제품 코드KPE

자문 위원회HO

결정Substantially Equivalent

기기 요약

eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) 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 2023-09-01 under 510(k) number K223674. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)?

eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K223674.

When did eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) receive FDA 510(k) clearance?

eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) received FDA 510(k) clearance on 2023-09-01, under 510(k) number K223674.

Who is the listed applicant for eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)?

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 (models 426030, 426040, 426110)?

The FDA product code for eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) is KPE.

Epic Medical Pte. , Ltd.를 신청인으로 등재한 기타 기록

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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