Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable

Pump, Infusion

Fresenius Kabi AG

The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Agilia Sp Infusion System, Agilia Sp Mc Wifi Infusion Pump, Agilia Link, Agilia Duo, Agilia Usb Cable.

Pre-market Notification Details

Device IDK210074
510k NumberK210074
Device Name:Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable
ClassificationPump, Infusion
Applicant Fresenius Kabi AG Else-Kroner-Str. 1 Bad Homburg,  DE 61346
ContactKeith Dunn
CorrespondentKeith Dunn
Fresenius Kabi LLC, USA 3 Corporate Dr Suite 300 Lake Zurich,  IL  60047
Product CodeFRN  
Subsequent Product CodeFPA
Subsequent Product CodeMRZ
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-12
Decision Date2022-03-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04086000856058 K210074 000

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