FDA 510(k)

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

K-Number: K223674 · 2023-09-01

Decision Date2023-09-01

Product CodeKPE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

eZSURE Empty Fluid Container (models 426030, 426040, 426110) is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2023-09-01 under approval number K223674. 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 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. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K223674.

When was eZSURE Empty Fluid Container (models 426030, 426040, 426110) approved by the FDA?

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

What company makes eZSURE Empty Fluid Container (models 426030, 426040, 426110)?

eZSURE Empty Fluid Container (models 426030, 426040, 426110) is manufactured by Epic Medical Pte. , Ltd..

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.