Cogent Hemodynamic Monitoring System; Cogent HMS— 510(k) K232048

Name: FDA 510(k) clearance K232048
Creator: U.S. Food and Drug Administration
Published: 2023-12-20

Substantially Equivalent

Icu Medical

FDA 510(k) clearance K232048 for Cogent Hemodynamic Monitoring System; Cogent HMS, Substantially Equivalent on 2023-12-20. Applicant: Icu Medical. Device class: 2.

Clearance details

Applicant: Icu Medical
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2023-07-10
Decision date: 2023-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.