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FDA 510(k)

CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC

K-Number: K844116 · 1985-05-28

ApplicantCritikon Company, LLC
Decision Date1985-05-28
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 1985-05-28 under 510(k) number K844116. 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 CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC?

CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC is a medical device that received FDA 510(k) clearance on 1985-05-28. The listed applicant is Critikon Company, LLC. The 510(k) number is K844116.

When did CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC receive FDA 510(k) clearance?

CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC received FDA 510(k) clearance on 1985-05-28, under 510(k) number K844116.

Who is the listed applicant for CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC?

The FDA 510(k) record lists Critikon Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC?

The FDA product code for CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC is DXG.

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Other records listing Critikon Company, LLC as applicant

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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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