Cogent Hemodynamic Monitoring System— 510(k) K152006

Substantially Equivalent

Icu Medical, Inc.

FDA 510(k) clearance K152006 for Cogent Hemodynamic Monitoring System, Substantially Equivalent on 2016-05-05. Applicant: Icu Medical, Inc..

Clearance details

Applicant: Icu Medical, Inc.
Product code: Code DXQ
Advisory panel: Cardiovascular
Date received: 2015-07-21
Decision date: 2016-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

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