FDA 510(k)

CARDIAC OUTPUT THERMODILUTION MODULE

K-Number: K771991 · 1977-11-03

Decision Date1977-11-03

Product CodeDXG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CARDIAC OUTPUT THERMODILUTION MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1977-11-03 under 510(k) number K771991. 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 CARDIAC OUTPUT THERMODILUTION MODULE?

CARDIAC OUTPUT THERMODILUTION MODULE is a medical device that received FDA 510(k) clearance on 1977-11-03. The listed applicant is Abbott Laboratories. The 510(k) number is K771991.

When did CARDIAC OUTPUT THERMODILUTION MODULE receive FDA 510(k) clearance?

CARDIAC OUTPUT THERMODILUTION MODULE received FDA 510(k) clearance on 1977-11-03, under 510(k) number K771991.

Who is the listed applicant for CARDIAC OUTPUT THERMODILUTION MODULE?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIAC OUTPUT THERMODILUTION MODULE?

The FDA product code for CARDIAC OUTPUT THERMODILUTION MODULE is 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.