Spectrum IQ Infusion System With Dose IQ Safety Software

Pump, Infusion

Baxter Healthcare Corporation

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Spectrum Iq Infusion System With Dose Iq Safety Software.

Pre-market Notification Details

Device IDK220417
510k NumberK220417
Device Name:Spectrum IQ Infusion System With Dose IQ Safety Software
ClassificationPump, Infusion
Applicant Baxter Healthcare Corporation 25212 W. Illinois Route 120 Round Lake,  IL  60073
ContactJennifer Hoogheem
CorrespondentJennifer Hoogheem
Baxter Healthcare Corporation 25212 W. Illinois Route 120 Round Lake,  IL  60073
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-14
Decision Date2022-04-29

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