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

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.

Clearance details

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

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