LifeShield Infusion Safety Software Suite— 510(k) K252130

Substantially Equivalent

Icu Medical, Inc.

FDA 510(k) clearance K252130 for LifeShield Infusion Safety Software Suite, Substantially Equivalent on 2026-04-02. Applicant: Icu Medical, Inc.. Device class: 2.

Clearance details

Applicant
Icu Medical, Inc.
Product code
Code PHC
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lake Forest, IL, US
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