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510(k) K251640

SIGMA Spectrum Infusion Pump with Master Drug Library by Baxter Healthcare Corporation — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2025
Date Received
May 29, 2025
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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