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FDA 510(k)

CRITIKON CARDIAC OUTPUT COMPUTER

K-Number: K831967 · 1983-10-28

ApplicantCritikon Company, LLC
Decision Date1983-10-28
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRITIKON CARDIAC OUTPUT COMPUTER 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 1983-10-28 under 510(k) number K831967. 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?

CRITIKON CARDIAC OUTPUT COMPUTER is a medical device that received FDA 510(k) clearance on 1983-10-28. The listed applicant is Critikon Company, LLC. The 510(k) number is K831967.

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

CRITIKON CARDIAC OUTPUT COMPUTER received FDA 510(k) clearance on 1983-10-28, under 510(k) number K831967.

Who is the listed applicant for CRITIKON CARDIAC OUTPUT COMPUTER?

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?

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

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Official Source

View on FDA Database →

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

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