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FDA 510(k)

CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM

K-Number: K081776 · 2008-07-22

ApplicantOmega Critical Care Limited
Decision Date2008-07-22
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM is the device name listed in this FDA 510(k) record. The listed applicant is Omega Critical Care Limited. It received FDA 510(k) clearance on 2008-07-22 under 510(k) number K081776. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM?

CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM is a medical device that received FDA 510(k) clearance on 2008-07-22. The listed applicant is Omega Critical Care Limited. The 510(k) number is K081776.

When did CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM receive FDA 510(k) clearance?

CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM received FDA 510(k) clearance on 2008-07-22, under 510(k) number K081776.

Who is the listed applicant for CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM?

The FDA 510(k) record lists Omega Critical Care Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM?

The FDA product code for CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM is DXG.

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Related Devices (Code: DXG)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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