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510(k) K222048

Spectrum IQ Infusion System with Dose IQ Safety Software by Baxter Healthcare Corporation — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2022
Date Received
July 12, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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