Class Class II

Getinge Assured MI Steam Migrating Integrator (K242795)

K242795 2024-10-15 Special
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Description

Getinge Assured MI Steam Migrating Integrator by Steritec Products Mfg. (A Getinge Group Company), an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242795
Clearance Date2024-10-15
Clearance TypeSpecial
Product CodeJOJ
Regulation Number880.2800

Categories

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Predicate lineage for K242795

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. Getinge Assured MI Steam Migrating Integrator (K242795) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K200252Getinge Assured MI Steam Migrating IntegratorSteritec Products Mfg Co, Inc.2020

Trace the full predicate network for K242795

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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