FDA 510(k)

CT 8000 DIGITAL INJECTION SYSTEM

K-Number: K912944 · 1992-02-04

Decision Date1992-02-04

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CT 8000 DIGITAL INJECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Group, Inc.. It received FDA 510(k) clearance on 1992-02-04 under 510(k) number K912944. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT 8000 DIGITAL INJECTION SYSTEM?

CT 8000 DIGITAL INJECTION SYSTEM is a medical device that received FDA 510(k) clearance on 1992-02-04. The listed applicant is Mallinckrodt Group, Inc.. The 510(k) number is K912944.

When did CT 8000 DIGITAL INJECTION SYSTEM receive FDA 510(k) clearance?

CT 8000 DIGITAL INJECTION SYSTEM received FDA 510(k) clearance on 1992-02-04, under 510(k) number K912944.

Who is the listed applicant for CT 8000 DIGITAL INJECTION SYSTEM?

The FDA 510(k) record lists Mallinckrodt Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT 8000 DIGITAL INJECTION SYSTEM?

The FDA product code for CT 8000 DIGITAL INJECTION SYSTEM is DXT.

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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.