FDA 510(k)

CONTINUOUS CARDIAC OUTPUT SYSTEM

K-Number: K932414 · 1994-11-14

Decision Date1994-11-14

Product CodeDXG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CONTINUOUS CARDIAC OUTPUT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1994-11-14 under 510(k) number K932414. 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 OUTPUT SYSTEM?

CONTINUOUS CARDIAC OUTPUT SYSTEM is a medical device that received FDA 510(k) clearance on 1994-11-14. The listed applicant is Abbott Laboratories. The 510(k) number is K932414.

When did CONTINUOUS CARDIAC OUTPUT SYSTEM receive FDA 510(k) clearance?

CONTINUOUS CARDIAC OUTPUT SYSTEM received FDA 510(k) clearance on 1994-11-14, under 510(k) number K932414.

Who is the listed applicant for CONTINUOUS CARDIAC OUTPUT SYSTEM?

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 CONTINUOUS CARDIAC OUTPUT SYSTEM?

The FDA product code for CONTINUOUS CARDIAC OUTPUT SYSTEM 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.