CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM— 510(k) K081776

Name: FDA 510(k) clearance K081776
Creator: U.S. Food and Drug Administration
Published: 2008-07-22

Substantially Equivalent

Omega Critical Care Limited

FDA 510(k) clearance K081776 for CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM, Substantially Equivalent on 2008-07-22. Applicant: Omega Critical Care Limited. Device class: 2.

Clearance details

Applicant: Omega Critical Care Limited
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2008-06-23
Decision date: 2008-07-22
Decision: Substantially Equivalent
Clearance type: Special
Location: East Kilbride, GB

Download summary PDF View on FDA.gov ↗

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