Class Class II

Ecomed Disposable Administration Sets (K234129)

K234129 2024-09-20 Traditional
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Description

Ecomed Disposable Administration Sets by Ecomed Solutions, LLC, an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK234129
Clearance Date2024-09-20
Clearance TypeTraditional
Product CodeFPA
Regulation Number880.5440

Categories

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Predicate lineage for K234129

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Ecomed Disposable Administration Sets (K234129) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K090012DISPOSABLE INFUSION SETShan Dong Wei Gao Group Medical Pol...2009
K060082TIANJIN MEDIS DISPOSABLE INFUSION SETTianjin Medis International Trade C...2006

Trace the full predicate network for K234129

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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